# K902135: Percutaneous Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Device Labs, Inc.
- Decided: Aug 1, 1990 after 83 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 22, 2006 · Not classified · Z-1148-06: The 9F device may contain a 10 F sheath instead of the 9F
- May 22, 2006 · Not classified · Z-1152-06: The 9F device may contain a 10 F sheath instead of the 9F
- May 22, 2006 · Not classified · Z-1149-06: The 9F device may contain a 10 F sheath instead of the 9F
- May 22, 2006 · Not classified · Z-1150-06: The 9F device may contain a 10 F sheath instead of the 9F
- May 22, 2006 · Not classified · Z-1151-06: The 9F device may contain a 10 F sheath instead of the 9F
- May 22, 2006 · Not classified · Z-1153-06: The 9F device may contain a 10 F sheath instead of the 9F
- Jun 30, 2005 · Not classified · Z-1096-05: The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Jun 30, 2005 · Not classified · Z-1098-05: The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Jun 30, 2005 · Not classified · Z-1095-05: The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Jun 30, 2005 · Not classified · Z-1094-05: The tear away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Jun 30, 2005 · Not classified · Z-1097-05: The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Jun 30, 2005 · Not classified · Z-1092-05: The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
- Jun 30, 2005 · Not classified · Z-1093-05: The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use

Source page: https://510kreport.com/device/K902135
Methodology: https://510kreport.com/methodology