The following data is part of a premarket notification filed by Cardio Vascular Concepts, Inc. with the FDA for Mollring Cutter.
| Device ID | K950813 |
| 510k Number | K950813 |
| Device Name: | MOLLRING CUTTER |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | CARDIO VASCULAR CONCEPTS, INC. 3260 ALPINE RD. Portola Valley, CA 94028 |
| Contact | Jay Lenker |
| Correspondent | Jay Lenker CARDIO VASCULAR CONCEPTS, INC. 3260 ALPINE RD. Portola Valley, CA 94028 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-22 |
| Decision Date | 1995-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102747 | K950813 | 000 |
| 00840663102730 | K950813 | 000 |
| 00840663102723 | K950813 | 000 |
| 00840663102716 | K950813 | 000 |
| 00840663102709 | K950813 | 000 |
| 00840663102693 | K950813 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MOLLRING CUTTER 74608298 1952810 Live/Registered |
LEMAITRE VASCULAR, INC. 1994-12-07 |