The following data is part of a premarket notification filed by East End Medical I Llc with the FDA for Safecross Transseptal Puncture And Introducer (tsp/i) System.
| Device ID | K203459 |
| 510k Number | K203459 |
| Device Name: | SafeCross Transseptal Puncture And Introducer (TSP/I) System |
| Classification | Introducer, Catheter |
| Applicant | East End Medical I LLC 1157 Sawgrass Corporate Parkway Sunrise, FL 33323 |
| Contact | Brij Maini |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants LLC 5 Lake Como Ct. Greenville, SC 29609 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-24 |
| Decision Date | 2021-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600035053013 | K203459 | 000 |
| 08600035053037 | K203459 | 000 |
| 08600035053020 | K203459 | 000 |