The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Perifuse Catheter.
Device ID | K121525 |
510k Number | K121525 |
Device Name: | PERIFUSE CATHETER |
Classification | Anesthesia Conduction Kit |
Applicant | SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
Contact | Christine Lloyd |
Correspondent | Christine Lloyd SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. Keene, NH 03431 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-23 |
Decision Date | 2012-08-02 |
Summary: | summary |