K973561 is an FDA 510(k) clearance for the MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on May 11, 1998, 234 days after receiving the submission on September 19, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K973561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1997 |
| Decision Date | May 11, 1998 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |