The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Kirwan L-aneurysm Clips And Applier, Kirwan Yasargil-type Aneurysm Clips And Appliers.
| Device ID | K060915 |
| 510k Number | K060915 |
| Device Name: | KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS |
| Classification | Clip, Aneurysm |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DRIVE Marshfield, MA 02050 |
| Contact | Kevin P Prario |
| Correspondent | Kevin P Prario KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DRIVE Marshfield, MA 02050 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-04 |
| Decision Date | 2007-04-17 |
| Summary: | summary |