The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Miscellaneous Pacing Lead.
| Device ID | K925168 |
| 510k Number | K925168 |
| Device Name: | MISCELLANEOUS PACING LEAD |
| Classification | Pacemaker Lead Adaptor |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | De Nieuwe |
| Correspondent | De Nieuwe OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1994-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00802526497537 | K925168 | 000 |
| 00836559003168 | K925168 | 000 |
| 00836559003151 | K925168 | 000 |
| 00836559003144 | K925168 | 000 |
| 00836559002710 | K925168 | 000 |
| 00836559002703 | K925168 | 000 |
| 00836559002680 | K925168 | 000 |
| 00836559002666 | K925168 | 000 |
| 00836559002642 | K925168 | 000 |
| 00836559002611 | K925168 | 000 |
| 00836559004752 | K925168 | 000 |
| 00836559006091 | K925168 | 000 |
| 00836559006411 | K925168 | 000 |
| 00802526497520 | K925168 | 000 |
| 00885672102739 | K925168 | 000 |
| 00885672102722 | K925168 | 000 |
| 00885672008284 | K925168 | 000 |
| 00885672008277 | K925168 | 000 |
| 00885672003692 | K925168 | 000 |
| 70836559002597 | K925168 | 000 |
| 70836559002580 | K925168 | 000 |
| 00836559009627 | K925168 | 000 |
| 00885672011222 | K925168 | 000 |