510(k) Report

510(k) · Cleared

Cleared

Angel Catheter

K160747510(k) TraditionalCleared Jul 28, 2016132-day reviewClass II21 CFR 870.3375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bio2 Medical, Inc. · PNS Short-Term Intravascular Filter Catheter

Cleared on Jul 28, 2016 as substantially equivalent to K073374 (William Cook Europe Aps, 2008) and 3 other predicates after a 132-day review. Its family tree reaches back 10 generations to 2000. 6 of the 49 devices in its family, counting itself, have a Class I recall.

Decided
Jul 28, 2016
Review
132 days
Class
Class II
Product code
PNS
Recalls
None
Predicates
4

Its longest line of descent runs back 10 generations to K001901 (2000). 48 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 6 of the 49 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2010: 1 other ancestor2008: 4 other ancestors1997: 2 other ancestors, 1 with a Class I recall12007: 1 other ancestor2003: 4 other ancestors1996: 2 other ancestors, 1 with a Class I recall12000: 3 other ancestors, 1 with a Class I recall11998: 2 other ancestors1990: 2 other ancestors, 1 with a Class I recall11989: 1 other ancestor1986: 1 other ancestor, 1 with a Class I recall12002: 2 other ancestors2006: 1 other ancestor2005: 4 other ancestors2004: 1 other ancestor1993: 2 other ancestors1991: 1 other ancestor1983: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestorK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalled×3: 3 generations cleared close together, K050185 (2005), K051417 (2005), K051991 (2005) K061179 · Powerhickman Long-Term Intravascular Catheter · C.R. Bard, Inc. · 2006K071538 · Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter · Arrow International, Inc. · 2007 · Class I recallK091709 · Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC · Edwards Lifesciences, LLC · 20091980199020002010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors, 1 with a Class I recall13 generations back: 8 other ancestors, 3 with a Class I recall34 generations back: 5 other ancestors, 1 with a Class I recall15 generations back: 10 other ancestors6 generations back: 6 other ancestors7 generations back: 2 other ancestors K091709 · Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC · Edwards Lifesciences, LLC · 2009K071538 · Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter · Arrow International, Inc. · 2007 · Class I recallK061179 · Powerhickman Long-Term Intravascular Catheter · C.R. Bard, Inc. · 2006K051991 · Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line · C.R. Bard, Inc. · 2005K051417 · 6 FR FL Powerhohn and Powerline Catheter · C.R. Bard, Inc. · 2005 · recalledK050185 · Powerhohn and Powerline Catheters · C.R. Bard, Inc. · 2005K033389 · Powerpicc Catheters, Models 3175155, 3175135 · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−10−50
  1. Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations between
  3. 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
  4. 2 generations backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
  5. 1 generation backK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
  6. This deviceK160747 Angel CatheterBio2 Medical, Inc. · 2016
Show all 10 generations
  1. Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 7 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
  5. 6 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
  6. 5 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
  7. 4 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
  8. 3 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
  9. 2 generations backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
  10. 1 generation backK091709 Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC · 2009
  11. This deviceK160747 Angel CatheterBio2 Medical, Inc. · 2016

Class I recalls in this family

  • K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…2 generations back · 2007
  • K955839 Multi-Med Multi-Lumen Central Venous Catheter2 generations back · 1996
  • K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…3 generations back · 2000
  • K900263 Antimicrobial Multi-Lumen Central Venous Catheter3 generations back · 1990
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−9K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−8K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−7K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20041
−6K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005—
−5K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051
−4K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005—
−3K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.2006—
−2K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous…Arrow International, Inc.2007Class I
−1K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC2009—
0 (this device)K160747Angel CatheterBio2 Medical, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198611
198910
199021
199110
199320
199621
199721
199820
199910
200031
200120
200220
200340
200410
200540
200610
200710
200840
201010
FIG. 1 — Lineage of K160747, 2000–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set
Summary page 5
…ter Predicate Device Name FDA 510(k) Number Cook® Celect® Vena Cava Filter K073374 Inferior Vena Cava (IVC) Filters Bard Eclipse™ Vena Cava Filter K093659…
William Cook Europe Aps2008—
*K093659Eclipse Filter System-Femoral Delivery Kit, Eclipse Filter System-Jugular/Subclavian…
Summary page 5
…® Celect® Vena Cava Filter K073374 Inferior Vena Cava (IVC) Filters Bard Eclipse™ Vena Cava Filter K093659 Edwards Multi-Med Central Venous Catheter K091709 Central Venous (CVC) Catheters…
C.R. Bard, Inc.2010—
*K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKIC
Summary page 5
…Filters Bard Eclipse™ Vena Cava Filter K093659 Edwards Multi-Med Central Venous Catheter K091709 Central Venous (CVC) Catheters ARROWG+ARD Blue Quad-Lumen Central…
Edwards Lifesciences, LLC2009—
*K962577Arrowgard Blue Quad-Lumen Central Venous Catheter
Summary page 5
…K091709 Central Venous (CVC) Catheters ARROWG+ARD Blue Quad-Lumen Central K962577 Venous Catheter IV. DEVICE DESCRIPTION The Angel® Catheter is a retrievable vena cava filter…
Arrow Intl., Inc.19971

Also cleared against K073374: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
  • K955839Multi-Med Multi-Lumen Central Venous CatheterBaxter Edwards · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
  • K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
  • K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 3 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
  • K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 3 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
  • K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • 18 of the 48 ancestors have a recall of any class; 6 have a Class I recall.
  • 5 other devices also cite its predicate K073374.

How does its category compare?

All PNS devices

PNS Short-Term Intravascular Filter Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · PNS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PNS

Too few PNS 510(k)s in any year since 2007 to give a median.

Recalls per year · PNS

No recall names PNS since 2007.

Adverse event reports per year · PNS

6in 2022

2017: 32018: 22021: 42022: 6
2007high 6 (2022) · low 0 (2007)2025

MAUDE reports naming product code PNS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—03
20180—02
20190—00
20200—00
20210—04
20220—06
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Angel® Catheter is intended to provide the combined functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter.

The Angel® Catheter is intended for short term use for the prevention of clinically significant pulmonary embolism (PE) in critically ill patients at high risk for PE or recurrent PE, and recognized contraindications to standard pharmacological thromboprophylaxis therapy.

The Angel® Catheter is also intended to provide access to the central venous system.

Indications for use as stated in the FDA summary.

Also cleared against K073374

5 other devices cite the same predicate.

  • K181757Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated · 2018
  • K152560Bard Snare Retrieval KitNeometrics, Inc. · 2015
  • K133681Crux Snare Filter Retrieval SetVolcano Corporation · 2014
  • K121629Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena Cava Filter Set for…William Cook Europe Aps · 2012
  • K112185Foursnare Vascular Retrieval SnareCook, Inc. · 20111 Class I recall

https://510kreport.com/device/K160747 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160747: Angel Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160747

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026