The following data is part of a premarket notification filed by Venturemed Group with the FDA for Flex Scoring Catheter.
| Device ID | K152789 |
| 510k Number | K152789 |
| Device Name: | FLEX SCORING CATHETER |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | VENTUREMED GROUP 5855 MONROE ST SUITE 220 A Sylvania, OH 43560 |
| Contact | Tiffini Diage |
| Correspondent | Tiffini Diage VENTUREMED GROUP 5855 MONROE ST SUITE 220 A Sylvania, OH 43560 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863656000318 | K152789 | 000 |
| 00863656000301 | K152789 | 000 |