510(k) Report

510(k) · Cleared

Cleared

Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter

K151638510(k) TraditionalCleared Nov 13, 2015149-day reviewClass II21 CFR 870.1250

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

Cathera, Inc. · DQY Catheter, Percutaneous

Cleared on Nov 13, 2015 as substantially equivalent to K021591 (Cordis Neurovascular, Inc., 2002) and 3 other predicates after a 149-day review. Its family tree reaches back 4 generations to 1995. 6 later devices descend from it.

Decided
Nov 13, 2015
Review
149 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K945904 (1995). 10 ancestors in all, the oldest K862117 (1986). 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor1999: 1 other ancestor1986: 1 other ancestor1997: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor2018: 1 descendant cleared2021: 2 descendants cleared2023: 1 descendant cleared2026: 2 descendants clearedK945904 · Scimed (R) Venture (TM) II Infusion Catheter · Scimed Peripheral Interventions · 1995K972518 · Transit/Rapidtransit/Speedster/Prowler Infusion Catheter · Cordis Neurovascular, Inc. · 1997×2: 2 generations cleared close together, K020680 (2002), K021591 (2002) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants K021591 · Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips · Cordis Neurovascular, Inc. · 2002 · recalledK020680 · Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips · Cordis Neurovascular, Inc. · 2002K972518 · Transit/Rapidtransit/Speedster/Prowler Infusion Catheter · Cordis Neurovascular, Inc. · 1997K945904 · Scimed (R) Venture (TM) II Infusion Catheter · Scimed Peripheral Interventions · 19950
  1. Root · 4 generations backK945904 Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions · 1995
  2. 3 generations backK972518 Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc. · 1997
  3. 2 generations backK020680 Prowler Select 10 and 14 Infusion Catheters with and Without…Cordis Neurovascular, Inc. · 2002
  4. 1 generation backK021591 Prowler Select (10, 14, and Plus) Infusion Catheters with and…Cordis Neurovascular, Inc. · 2002 · Recalled
  5. This deviceK151638 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom…Cathera, Inc. · 2015
  6. Descendant · cites it directly · 4 of its ownK180959 Phenom 27 CatheterCathera, Inc. · 2018
  7. Descendant · cites it directly · 2 of its ownK210230 Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021
  8. Descendant · 2 generations on · 0 of its ownK260199 SLIM MicrocatheterBalt USA, LLC · 2026
  9. Descendant · 2 generations on · 0 of its ownK251668 SurfRider 13 MicrocatheterKaneka Americas Holding, Inc. · 2026
  10. Descendant · 2 generations on · 0 of its ownK222023 RayFlowHexacath · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12021: 22023: 12026: 2
2018high 2 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K180959Phenom 27 CatheterCathera, Inc. · 2018 · cites it directly4descendants
  • K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021 · cites it directly2descendants
  • K260199SLIM MicrocatheterBalt USA, LLC · 2026 · 2 generations on0descendants
  • K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc. · 2026 · 2 generations on0descendants
  • K222023RayFlowHexacath · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945904Scimed (R) Venture (TM) II Infusion CatheterScimed Peripheral Interventions1995—
−3K972518Transit/Rapidtransit/Speedster/Prowler Infusion CatheterCordis Neurovascular, Inc.1997—
−2K020680Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.2002—
−1K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without…Cordis Neurovascular, Inc.20022
0 (this device)K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.2015—
+1K180959Phenom 27 CatheterCathera, Inc.2018—
+1K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular2021—
+2K260199SLIM MicrocatheterBalt USA, LLC2026—
+2K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.2026—
+2K222023RayFlowHexacath2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199510
199710
199910
200110
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202120
202310
202620
FIG. 1 — Lineage of K151638, 1995–2026Source: 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.

Planning a device in DQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped Tips
Summary page 4
…t Codes: Continuous Flush Catheter (21 CFR 870.1210, Product Code KRA) Predicate Devices: Prowler® 14 Infusion Catheter (510K # K021591) Prowler® Plus Infusion Catheter (510K # K993266) Marksman™ Catheter (510K # K09155…
Cordis Neurovascular, Inc.20022
*K993266Prowler Plus Infusion Catheter
Summary page 4
…(21 CFR 870.1210, Product Code KRA) Predicate Devices: Prowler® 14 Infusion Catheter (510K # K021591) Prowler® Plus Infusion Catheter (510K # K993266) Marksman™ Catheter (510K # K091559) Tracker® Infusion Catheter (510k # K862117) D…
Cordis Neurovascular, Inc.1999—
*K091559Marksmann Catheter
Summary page 4
…Prowler® 14 Infusion Catheter (510K # K021591) Prowler® Plus Infusion Catheter (510K # K993266) Marksman™ Catheter (510K # K091559) Tracker® Infusion Catheter (510k # K862117) Device Description: The Phenom™ Catheters are variable stif…
Chestnut Medical Technologies, Inc.2009—
*K862117Tracker Infusion Catheter
Summary page 4
…Prowler® Plus Infusion Catheter (510K # K993266) Marksman™ Catheter (510K # K091559) Tracker® Infusion Catheter (510k # K862117) Device Description: The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous va…
Target Therapeutics1986—

Also cleared against K021591: 4 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180959Phenom 27 CatheterCathera, Inc.20184
K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20212
K213451Spartan MC 0165Spartan Micro20210

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K180959 (Cathera, Inc., 2018) has gone furthest, with 4 descendants of its own.
  • 4 other devices also cite its predicate K021591.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Phenom™ Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Indications for use as stated in the FDA summary.

Also cleared against K021591

4 other devices cite the same predicate.

  • K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL · 2022
  • K210838Prowler Select Plus; Prowler EXMedos International SARL · 2021
  • K113289Orion Micro CatheterMicro Therapeutics, Inc. · 2012
  • K043538Hypertransit Infusion CatheterCordis Neurovascular, Inc. · 2005

More from Cathera, Inc.

2 FDA decisions under this applicant name. See the company

  • K180959Phenom 27 CatheterCathera, Inc. · 2018

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K151638 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151638: Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151638

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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