510(k) · Cleared
ClearedCook Vascular Serpenta Coronary Sinus Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Vascular, Inc. · DYB Introducer, Catheter
Cleared on May 27, 2003 as substantially equivalent to K012130 (Medtronic Vascular, 2001) and 2 other predicates after a 182-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- May 27, 2003
- Review
- 182 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K893658 (1989). 31 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet.
- Root · 3 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 2 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 1 generation backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- This deviceK023937 Cook Vascular Serpenta Coronary Sinus Introducer SystemCook Vascular, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −2 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −1 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| 0 (this device) | K023937 | Cook Vascular Serpenta Coronary Sinus Introducer System | Cook Vascular, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
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 14 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 31 ancestors have a recall of any class.
- 5 other devices also cite its predicate K012130.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The SERPENTATMCoronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or I'eads into vessels of the left heart via the coronary sinus. SERPENTATMCoronary Sinus Introducer System is supplied sterile and intended for one time use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023937: Cook Vascular Serpenta Coronary Sinus Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023937
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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