510(k) K221914
K221914 is an FDA 510(k) premarket notification submitted by Contract Medical International, GmbH for the device "Catapult Guide Sheath". The FDA issued a decision of Substantially Equivalent on Jul 29, 2022. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Contract Medical International, GmbH has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2022
- Date Received
- Jun 30, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)