# K201116: Abiomed 23 Fr Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Jun 15, 2020 after 49 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 13 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934901 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122084: Introducer Set, Model Adelante-S Series, Oscor, Inc. (2012) Summary page 4.

## Recalls of this device
- Jun 11, 2026 · Class I · Z-2685-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2689-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2688-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2681-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2690-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2682-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2691-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2687-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2684-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2693-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2683-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2686-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th
- Jun 11, 2026 · Class I · Z-2692-2026: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th

## Indications for use
The Abiomed 23 Fr Sheath is intended for introduction of pacing leads or catheters.

Source page: https://510kreport.com/device/K201116
Methodology: https://510kreport.com/methodology