Percutaneous Sheath Introducer Kit
FDA product code OFL · Class II (moderate risk) · 21 CFR 870.1340 · Cardiovascular
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
0510(k) clearances
0PMA approvals
5recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2393-2026 Class I | Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-1912-2026 Class II | PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code:…Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Arrow International, LLC | 03/11/2026Open, Classified |
| Z-1737-2025 Class II | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15…Due to a potential open seal in the sterile barrier packaging. | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-1735-2025 Class II | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34…Due to a potential open seal in the sterile barrier packaging. | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-0500-2023 Class II | STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascularMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |