510(k) Report

510(k) · Cleared

Cleared

Evalve Steerable Guide Catheter, Model SGC01ST

K091596510(k) SpecialCleared Jul 2, 200930-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

Evalve, Inc. · DRA Catheter, Steerable

Cleared on Jul 2, 2009 as substantially equivalent to K083793 (Evalve, Inc., 2009) after a 30-day review. Its family tree reaches back 4 generations to 2001. 7 later devices descend from it.

Decided
Jul 2, 2009
Review
30 days
Class
Class II
Product code
DRA
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K002054 (2001). 10 ancestors in all, the oldest K964518 (1997). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 2 other ancestors2004: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor2011: 1 descendant cleared2016: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant clearedK002054 · 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. · 2005K083793 · Steerable Guide Catheter · Evalve, Inc. · 20091995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants K083793 · 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. · 20010
  1. Root · 4 generations backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
  2. 3 generations backK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
  3. 2 generations backK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
  4. 1 generation backK083793 Steerable Guide CatheterEvalve, Inc. · 2009
  5. This deviceK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
  6. Descendant · cites it directly · 6 of its ownK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010
  7. Descendant · cites it directly · 5 of its ownK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  8. Descendant · 2 generations on · 2 of its ownK120086 Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions…Cardiosolutions · 2012
  9. Descendant · 3 generations on · 1 of its ownK131332 Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc. · 2013
  10. Descendant · cites it directly · 1 of its ownK112239 Steerable Guide CatheterAbbott Vascular · 2011

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 22011: 12012: 12013: 12014: 12016: 1
2010high 2 (2010) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010 · cites it directly6descendants
  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010 · cites it directly5descendants
  • K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions · 2012 · 2 generations on2descendants
  • K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc. · 2013 · 3 generations on1descendant
  • K112239Steerable Guide CatheterAbbott Vascular · 2011 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002054X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90…Appriva Medical, Inc.2001—
−3K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with…Appriva Medical, Inc.2001—
−2K043084Premere Delivery Sheath, Model PDSVelocimed, Inc.2005—
−1K083793Steerable Guide CatheterEvalve, Inc.2009—
0 (this device)K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.2009—
+1K093866Evalve Steerable Guide CatheterEvalve, Inc.2010—
+1K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.2010—
+2K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro…Cardiosolutions2012—
+3K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc.2013—
+1K112239Steerable Guide CatheterAbbott Vascular2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200410
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201110
201210
201310
201410
201610
FIG. 1 — Lineage of K091596, 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? (1)

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 1
…4045 Campbell Avenue Menlo Park, CA 94025 Phone: (650) 330-8100 Date of Preparation May 29, 2009 Predicate K083793 Evalve Steerable Guide Catheter Intended Use: The Evalve Steerable Guide Catheter is used for int…
Evalve, Inc.2009—

Also cleared against K083793: 4 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K093866Evalve Steerable Guide CatheterEvalve, Inc.20106
K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.20105
K112239Steerable Guide CatheterAbbott Vascular20111
K161985Steerable Guide CatheterAbbott Vascular20160

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 8 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K093866 (Evalve, Inc., 2010) has gone furthest, with 6 descendants of its own.
  • 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. 2009, 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 Evalve 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.

  • K161985Steerable Guide CatheterAbbott Vascular · 2016
  • K112239Steerable Guide CatheterAbbott Vascular · 2011
  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010

More from Evalve, Inc.

4 FDA decisions under this applicant name. See the company

  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010
  • K083793Steerable Guide CatheterEvalve, Inc. · 2009

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/K091596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091596: Evalve Steerable Guide Catheter, Model SGC01ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091596

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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