The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Capiox Arterial Filter.
Device ID | K943917 |
510k Number | K943917 |
Device Name: | CAPIOX ARTERIAL FILTER |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
Product Code | DTM |
CFR Regulation Number | 870.4260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-11 |
Decision Date | 1995-07-25 |