The following data is part of a premarket notification filed by Craig & Craig, Inc. with the FDA for Myowire-atemporary Cardiac Pacing Wire.
| Device ID | K803086 |
| 510k Number | K803086 |
| Device Name: | MYOWIRE-ATEMPORARY CARDIAC PACING WIRE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | CRAIG & CRAIG, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-08 |
| Decision Date | 1981-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884389901496 | K803086 | 000 |