510(k) K903340 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
STERILE URETHRAL CATHETER PROCEDURE KITS
| Applicant | Superior Healthcare Group, Inc., Cumberland RI, US |
| Decision | Unknown, Oct 4, 1990 |
| Received | Jul 25, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" Open, Classified |
FCM | None listed |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter
Product Code: 2480
Intended for urinary drainage from the bladder of a patient Open, Classified |
FCM | None listed |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm)
Product Code: 3408
Intended for urinary drainage from the bladder of a patient Open, Classified |
FCM | None listed |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm)
Product Code: 3410
Intended for urinary drainage from the bladder of a patient Open, Classified |
FCM | None listed |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Vinyl Catheter
Product Code: 3420
Intended for urinary drainage from the bladder of a patient Open, Classified |
FCM | None listed |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag
Product Code: 3450
Intended for urinary drainage from the bladder of a patient Open, Classified |
FCM | None listed |
| Dec 2, 2022 | Cardinal Health Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag
Product Code: 3450LF
Intended for urinary drainage from the bladder of a patient. Open, Classified |
FCM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.