The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Cps Aim Sl Slittable Inner Catheter.
Device ID | K082932 |
510k Number | K082932 |
Device Name: | CPS AIM SL SLITTABLE INNER CATHETER |
Classification | Catheter, Percutaneous |
Applicant | ST. JUDE MEDICAL 15900 VALLEY VIEW COURT Sylmar,, CA 91342 |
Contact | Colleen Canan |
Correspondent | Colleen Canan ST. JUDE MEDICAL 15900 VALLEY VIEW COURT Sylmar,, CA 91342 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-01 |
Decision Date | 2008-12-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05414734508889 | K082932 | 000 |
05414734218184 | K082932 | 000 |