DATASCOPE BALLOON DILATATION CATHETER— 510(k) K863608
Substantially EquivalentDatascope Corp.
FDA 510(k) clearance K863608 for DATASCOPE BALLOON DILATATION CATHETER, Substantially Equivalent on 1987-02-10. Applicant: Datascope Corp..
Clearance details
- Applicant
- Datascope Corp.
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, NJ, US
More clearances from Datascope Corp.
view all- K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
- K181122 — CARDIOSAVE Intra-Aortic Balloon Pump
- K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
- K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
- K151254 — CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
Data sourced from openFDA. This site is unofficial and independent of the FDA.