Atlas FDA

STERILE URETHRAL CATHETER PROCEDURE KITS

FDA 510(k) clearance K903340 · decided 1990-10-04

Clearance details

K-number
K903340
Device name
STERILE URETHRAL CATHETER PROCEDURE KITS
Applicant
Superior Healthcare Group, Inc.
Decision
Unknown
Date received
1990-07-25
Decision date
1990-10-04
Days to decision
71 days
Clearance type
Traditional
Product code
FCM
Device class
2
Regulation number
876.5130
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Cumberland, RI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRA recall (Z-1045-2024)Cardinal Health 200, LLC2024-02-16
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code recall (Z-0356-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Prod recall (Z-0357-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Prod recall (Z-0358-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary dra recall (Z-0359-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connec recall (Z-0360-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connec recall (Z-0361-2023)Cardinal Health2022-12-02