510(k) Report

510(k) · Cleared

Cleared

Steerable Guide Catheter

K161985510(k) SpecialCleared Aug 7, 201619-day reviewClass II21 CFR 870.1280

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

Abbott Vascular · DRA Catheter, Steerable

Cleared on Aug 7, 2016 as substantially equivalent to K083793 (Evalve, Inc., 2009) and 4 other predicates after a 19-day review. Its family tree reaches back 8 generations to 2001.

Decided
Aug 7, 2016
Review
19 days
Class
Class II
Product code
DRA
Recalls
None
Predicates
5

Its longest line of descent runs back 8 generations to K002054 (2001). 14 ancestors in all, the oldest K964518 (1997). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 2 other ancestors2004: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestorK002054 · X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 · Appriva Medical, Inc. · 2001K012489 · Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10 · Appriva Medical, Inc. · 2001K043084 · Premere Delivery Sheath, Model PDS · Velocimed, Inc. · 2005×2: 2 generations cleared close together, K083793 (2009), K091596 (2009) K093866 · Evalve Steerable Guide Catheter · Evalve, Inc. · 2010K100789 · Modificaton to: Steerable Guide Catheter, Model SGC01ST · Evalve, Inc. · 2010K112239 · Steerable Guide Catheter · Abbott Vascular · 201119952000200520102015
Other ancestors, by generation 2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor K112239 · Steerable Guide Catheter · Abbott Vascular · 2011K100789 · Modificaton to: Steerable Guide Catheter, Model SGC01ST · Evalve, Inc. · 2010K093866 · Evalve Steerable Guide Catheter · Evalve, Inc. · 2010K091596 · Evalve Steerable Guide Catheter, Model SGC01ST · Evalve, Inc. · 2009K083793 · Steerable Guide Catheter · Evalve, Inc. · 2009K043084 · Premere Delivery Sheath, Model PDS · Velocimed, Inc. · 2005K012489 · Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10 · Appriva Medical, Inc. · 2001K002054 · X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 · Appriva Medical, Inc. · 2001−50
  1. Root · 8 generations backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
  2. 7 generations backK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
  3. 6 generations backK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
  4. 5 generations backK083793 Steerable Guide CatheterEvalve, Inc. · 2009
  5. 4 generations backK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
  6. 3 generations backK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010
  7. 2 generations backK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  8. 1 generation backK112239 Steerable Guide CatheterAbbott Vascular · 2011
  9. This deviceK161985 Steerable Guide CatheterAbbott Vascular · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K002054X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90…Appriva Medical, Inc.2001—
−7K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with…Appriva Medical, Inc.2001—
−6K043084Premere Delivery Sheath, Model PDSVelocimed, Inc.2005—
−5K083793Steerable Guide CatheterEvalve, Inc.2009—
−4K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.2009—
−3K093866Evalve Steerable Guide CatheterEvalve, Inc.2010—
−2K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.2010—
−1K112239Steerable Guide CatheterAbbott Vascular2011—
0 (this device)K161985Steerable Guide CatheterAbbott Vascular2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200410
200520
FIG. 1 — Lineage of K161985, 2001–2016Source: 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.

Planning a device in DRA? 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 DRA device

  1. #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 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? (5)

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
*K083793Steerable Guide Catheter
Summary page 4
…uide Catheter 8. Device Common Name Steerable Catheter 9. Device Classification Name Catheter, Steerable 10. Predicate Device Name K083793 Steerable Guide Catheter K091596 Steerable Guide Catheter…
Evalve, Inc.2009—
*K091596Evalve Steerable Guide Catheter, Model SGC01ST
Summary page 4
…9. Device Classification Name Catheter, Steerable 10. Predicate Device Name K083793 Steerable Guide Catheter K091596 Steerable Guide Catheter K093866 Steerable Guide Catheter…
Evalve, Inc.2009—
*K093866Evalve Steerable Guide Catheter
Summary page 4
…Device Name K083793 Steerable Guide Catheter K091596 Steerable Guide Catheter K093866 Steerable Guide Catheter K100789 Steerable Guide Catheter…
Evalve, Inc.2010—
*K100789Modificaton to: Steerable Guide Catheter, Model SGC01ST
Summary page 4
…K091596 Steerable Guide Catheter K093866 Steerable Guide Catheter K100789 Steerable Guide Catheter K112239 Steerable Guide Catheter 11. Device Description The…
Evalve, Inc.2010—
*K112239Steerable Guide Catheter
Summary page 4
…K093866 Steerable Guide Catheter K100789 Steerable Guide Catheter K112239 Steerable Guide Catheter 11. Device Description The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO…
Abbott Vascular2011—

Also cleared against K083793: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K083793.

How does its category compare?

All DRA devices

DRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · DRA

1in 2025

2007: 12008: 12009: 22010: 32011: 12012: 42014: 12015: 12016: 42017: 22018: 12019: 22020: 12021: 12022: 22023: 32025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRA

89in 2023

2010: 29 days median2012: 70 days median2016: 123 days median2023: 89 days median
2007high 123 (2016) · low 29 (2010)2026

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

Recalls per year · DRA

4so far in 2026, the most since 2007

2008: 12011: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRA

4,018in 2025

2007: 62008: 232009: 52010: 22011: 1552012: 892013: 1132014: 2122015: 3502016: 4812017: 6252018: 6332019: 7002020: 7032021: 7412022: 6522023: 7882024: 1,9622025: 4,018
2007high 4,018 (2025) · low 2 (2010)2025

MAUDE reports naming product code DRA, 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
20071—06
20081—123
20092—05
201032902
20111—1155
2012470089
20130—0113
20141—0212
20151—0350
201641230481
20172—0625
20181—0633
20192—0700
20201—0703
20211—0741
20222—0652
20233890788
20240—01,962
20251—04,018
20261—4—

What is it indicated for?

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart

through the interatrial septum.

Indications for use as stated in the FDA summary.

Also cleared against K083793

4 other devices cite the same predicate.

  • K112239Steerable Guide CatheterAbbott Vascular · 2011
  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010
  • K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009

More from Abbott Vascular

360 FDA decisions under this applicant name. See the company

  • P110019/S145XIENCE PRO5 Everolimus Eluting Coronary Stent System (XIENCE PRO5), XIENCE Skypoint Everolimus Eluting…Abbott Vascular · 2026
  • P110019/S144XIENCE PROS Everolimus Eluting Coronary Stent System (XIENCE PRO5); XIENCE Skypoint Everolimus Eluting…Abbott Vascular · 2026
  • P110019/S142XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent SystemsAbbott Vascular · 2026
  • P110019/S141XIENCE Alpine™, XIENCE Sierra™, XIENCE PRO™ S, and XIENCE Skypoint™ Everolimus Eluting Coronary Stent SystemsAbbott Vascular · 2026
  • P110019/S140XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent…Abbott Vascular · 2026

Recent decisions in DRA

The DRA category page

  • K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
  • K250529Globe Introducer (601-01001)Kardium, Inc. · 2025
  • K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 20233 recalls
  • K232321FlexCath Contour™ Steerable SheathMedtronic, Inc. · 2023
  • K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 20231 Class I recall

https://510kreport.com/device/K161985 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161985: Steerable Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161985

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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