EYTClass I
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Gastroenterology, Urology · 21 CFR 876.5250
MDR events12All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances4All time
Recent MDR events
12 adverse event reports on file
- UNKNOWNMay 6, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01004
- UNKNOWNMay 6, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01004
- NON-ADHESIVE CONDOM CATHETERJun 4, 2015InjuryCook, Inc.1820334-2015-00331
- HEMAFLEX PTCA SHEATH KITJan 10, 1994InjuryBard, Incorporated15419
- 10 FRENCH SHEATHAug 2, 1993Universal Medical Instrument Corporation9838
- PERCUTANEOUS SHEATH INTRODUCER KITJan 5, 1993DeathArrow International2069
- UNKNOWNNov 4, 1992InjuryUniversal Medical Instrument Corporation1647
- CORDIS LONG SHEATH SET, 7 FRENCHSep 14, 1992DeathCordis1386
- SHEATH INTRODUCER KIT 6.0 FR.Aug 5, 1992InjuryArrow International4899
- MULLINS TRANSSIPTAL SHEATHJul 31, 1992MalfunctionUnknown4716
Event type breakdown
Injury7
Death2
Malfunction2
Unspecified1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Kit Pak, Inc.May 18, 1994
K934080 · URINARY DRAINAGE BAG
- Kendall Healthcare Products Co. Div.Of Tyco HealthApr 11, 1994
K935774 · CURITY FAST-CATH FEMALE CATHETER KIT
- Sierra Laboratories, Inc.Aug 2, 1988
K883057 · COMFORT CATH MALE EXTERNAL CATHETER
- Cook Urological, Inc.Aug 2, 1988
K883119 · VPI NON-ADHESIVE CONDOM CATHETER