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 |