AIR-BAND RADIAL COMPRESSION DEVICE— 510(k) K122405
Substantially EquivalentDatascope Corp., Cardiac Assist Division
FDA 510(k) clearance K122405 for AIR-BAND RADIAL COMPRESSION DEVICE, Substantially Equivalent on 2012-11-09. Applicant: Datascope Corp., Cardiac Assist Division. Device class: 2.
Clearance details
- Applicant
- Datascope Corp., Cardiac Assist Division
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfield, NJ, US
Recent devices under product code DXC
view all- K262086 — PreludeSYNC Radial Compression Device
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K254060 — Life Saving Tourniquet
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
More clearances from Datascope Corp., Cardiac Assist Division
view all- K122628 — SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
- K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
- K091449 — DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
Adverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.