The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Extension Passer Tunneling System (38 Cm), Model 3555-38; Medtronic Extension Passer Tunneling System (60 Cm),.
| Device ID | K000105 |
| 510k Number | K000105 |
| Device Name: | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | MEDTRONIC VASCULAR 11660 WAYZATA BLVD. Minnetonka, MN 55305 |
| Contact | Pam Schaub |
| Correspondent | Pam Schaub MEDTRONIC VASCULAR 11660 WAYZATA BLVD. Minnetonka, MN 55305 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-14 |
| Decision Date | 2000-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169986473 | K000105 | 000 |
| 00643169953604 | K000105 | 000 |
| 00643169887572 | K000105 | 000 |
| 00643169887565 | K000105 | 000 |
| 00673978858784 | K000105 | 000 |
| 00673978858777 | K000105 | 000 |