The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 8 Fr. Triguideflex Guiding Catheters.
Device ID | K913830 |
510k Number | K913830 |
Device Name: | SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS |
Classification | Catheter, Percutaneous |
Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
Contact | Mercedes P Bayani |
Correspondent | Mercedes P Bayani SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-26 |
Decision Date | 1991-11-22 |