The following data is part of a premarket notification filed by Transseptal Solutions Ltd. with the FDA for Tsp Crosser Transseptal Access System.
| Device ID | K181088 |
| 510k Number | K181088 |
| Device Name: | TSP Crosser Transseptal Access System |
| Classification | Introducer, Catheter |
| Applicant | Transseptal Solutions Ltd. 10 HaGavish St., P.O. Box 4060 Natanya, IL 4250708 |
| Contact | Mary P. Legraw |
| Correspondent | Mary P. Legraw Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, MA 01752 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-25 |
| Decision Date | 2018-09-28 |
| Summary: | summary |