# K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: Aug 14, 2012 after 209 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000659 (2000). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001) Summary page 1.
- K053171: Merit Impress Diagnostic Catheter, Merit Medical Systems, Inc. (2006) Summary page 3.
- K101776: Scoutpro Acs, Biotronik, Inc. (2010) Summary page 1.

## Most influential descendants
- K152116: 5.5 F Worley Advanced LVI Lateral Vein Introducer (2015), 1 descendant of its own
- K260459: VANES Delivery System (VDS) (2026), 0 descendants of its own
- K133501: Leadliner CS Lead Delivery System (2014), 0 descendants of its own

## Recalls of this device
- Jun 11, 2024 · Class II · Z-2571-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat
- Jun 11, 2024 · Class II · Z-2577-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat

## Indications for use
For the introduction of various types of pacing or defibrillator leads and catheters.

Source page: https://510kreport.com/device/K120158
Methodology: https://510kreport.com/methodology