K010021 is an FDA 510(k) clearance for the MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S. 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 February 23, 2001, 51 days after receiving the submission on January 3, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K010021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2001 |
| Decision Date | February 23, 2001 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |