The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Vascular Catheter Model Number 3621-1.
| Device ID | K883313 |
| 510k Number | K883313 |
| Device Name: | PMT VASCULAR CATHETER MODEL NUMBER 3621-1 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Al Iversen |
| Correspondent | Al Iversen PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-05 |
| Decision Date | 1988-10-04 |