The following data is part of a premarket notification filed by Rex Medical with the FDA for Splitwire Percutaneous Transluminal Angioplasty Scoring Device.
| Device ID | K113103 |
| 510k Number | K113103 |
| Device Name: | SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-05-22 |
| Summary: | summary |