# K023937: Cook Vascular Serpenta Coronary Sinus Introducer System

- Pathway: 510(k) (Traditional)
- Applicant: Cook Vascular, Inc.
- Decided: May 27, 2003 after 182 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K893658 (1989). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001)
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218, Medtronic Vascular (2001)
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001)
- (no number) Cook Introducer: named in the summary without a submission number

## Indications for use
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

Source page: https://510kreport.com/device/K023937
Methodology: https://510kreport.com/methodology