K935380 is an FDA 510(k) clearance for the VASCULAR ACCESS CATHETER ACCESSORIES. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 17, 1995, 466 days after receiving the submission on November 8, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K935380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 1993 |
| Decision Date | February 17, 1995 |
| Days to Decision | 466 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 |