The following data is part of a premarket notification filed by Ablative Solutions, Inc. with the FDA for Peregrine System Infusion Catheter.
| Device ID | K140637 |
| 510k Number | K140637 |
| Device Name: | PEREGRINE SYSTEM INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | ABLATIVE SOLUTIONS, INC. 801 Hermosa Way Menlo Park, CA 94025 |
| Contact | Sharon Rockwell |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-03-12 |
| Decision Date | 2014-03-26 |
| Summary: | summary |