K103551 is an FDA 510(k) clearance for the INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 25, 2011, 113 days after receiving the submission on December 2, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K103551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2010 |
| Decision Date | March 25, 2011 |
| Days to Decision | 113 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 |