The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Schneider Match-35 Percutaneous Transluminal Angio.
Device ID | K926271 |
510k Number | K926271 |
Device Name: | SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
Contact | Howard B Wittels |
Correspondent | Howard B Wittels SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1993-06-07 |