The following data is part of a premarket notification filed by Irvine Biomedical, Inc. A St.jude Medical Company with the FDA for Viewflex Xtra Ice Catheter.
| Device ID | K133853 |
| 510k Number | K133853 |
| Device Name: | VIEWFLEX XTRA ICE CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY 2375 MORSE AVENUE Irvine, CA 92614 |
| Contact | Jennifer Correa |
| Correspondent | Jennifer Correa IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY 2375 MORSE AVENUE Irvine, CA 92614 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067002082 | K133853 | 000 |