K001901 is an FDA 510(k) clearance for the POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135. 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 September 19, 2000, 89 days after receiving the submission on June 22, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K001901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2000 |
| Decision Date | September 19, 2000 |
| Days to Decision | 89 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 |