The following data is part of a premarket notification filed by Cardiofocus, Inc. with the FDA for Heartlight Deflectable Sheath.
| Device ID | K152310 |
| 510k Number | K152310 |
| Device Name: | HeartLight Deflectable Sheath |
| Classification | Catheter, Steerable |
| Applicant | CARDIOFOCUS, INC. 500 NICKERSON ROAD SUITE 500-200 Marlborough, MA 01752 |
| Contact | Seema Paliwal |
| Correspondent | Seema Paliwal CARDIOFOCUS, INC. 500 NICKERSON ROAD SUITE 500-200 Marlborough, MA 01752 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-14 |
| Decision Date | 2016-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868976000147 | K152310 | 000 |