The following data is part of a premarket notification filed by Possis Medical, Inc. with the FDA for 3.2-5mm Unipolar Lead Upsizing Kit, Model Ak 100.
| Device ID | K900605 |
| 510k Number | K900605 |
| Device Name: | 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis, MN 55427 |
| Contact | Robert J Scott |
| Correspondent | Robert J Scott POSSIS MEDICAL, INC. 8325 10TH AVENUE NORTH Minneapolis, MN 55427 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-08 |
| Decision Date | 1990-03-06 |