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 |