The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Aim Mediguide Enabled Inner Catheter, Cps Aim Mediguide Enabled Inner Catheter.
Device ID | K142235 |
510k Number | K142235 |
Device Name: | CPS Aim MediGuide Enabled Inner Catheter, CPS Aim Mediguide Enabled Inner Catheter |
Classification | Catheter, Percutaneous |
Applicant | St. Jude Medical 15900 Valley View Court Sylmar, CA 91342 |
Contact | Zachary Price |
Correspondent | Zachary Price St. Jude Medical 15900 Valley View Court Sylmar, CA 91342 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-13 |
Decision Date | 2014-12-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05414734509541 | K142235 | 000 |
05414734509534 | K142235 | 000 |
05414734509527 | K142235 | 000 |
05414734509510 | K142235 | 000 |
05414734509503 | K142235 | 000 |