K082362 is an FDA 510(k) clearance for the SURSHIELD SAFETY I.V. CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 17, 2008, 30 days after receiving the submission on August 18, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K082362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2008 |
| Decision Date | September 17, 2008 |
| Days to Decision | 30 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 |