The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions Pv .014 Platinum.
| Device ID | K143701 |
| 510k Number | K143701 |
| Device Name: | EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Marcus Garcia |
| Correspondent | Elaine Alan VOLCANO CORPORATION 1 FORTUNE DRIVE Billerica, MA 01821 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-08-26 |
| Summary: | summary |