K954104 is an FDA 510(k) clearance for the PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 21, 1995, 82 days after receiving the submission on August 31, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K954104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1995 |
| Decision Date | November 21, 1995 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |