The following data is part of a premarket notification filed by Contract Medical International Gmbh with the FDA for Catapult Guide Sheath.
| Device ID | K221914 |
| 510k Number | K221914 |
| Device Name: | Catapult Guide Sheath |
| Classification | Introducer, Catheter |
| Applicant | Contract Medical International GmbH Lauensteiner Strasse 37 Dresden, DE 01277 |
| Contact | Juliana Vaz Nuernberger |
| Correspondent | Jan Kubicek Contract Medical International S.r.o. Vazni 848 Hradec Kralove, CZ 50011 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-30 |
| Decision Date | 2022-07-29 |