K081210 is an FDA 510(k) clearance for the NIPRO SAFETOUCH HUBER INFUSTION SET. This device is classified as a Set, Administration, Intravascular (Class II — Special Controls, product code FPA).
Submitted by Nipro Medical Corp. (Doral, US). The FDA issued a Cleared decision on October 21, 2008, 175 days after receiving the submission on April 29, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K081210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2008 |
| Decision Date | October 21, 2008 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |