DeviceClearance

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case— 510(k) K163542

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K163542 for CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case, Substantially Equivalent on 2017-01-31. Applicant: Datascope Corp.. Device class: 2.

Clearance details

Applicant
Datascope Corp.
Product code
Code DSP
Device class
Class 2
Regulation
21 CFR 870.3535
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Manwah, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DSP

product code DSP
Death
317
Injury
566
Malfunction
36,831
Other
4
Total
37,718

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 →

Recalls naming K163542

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163542.

Data sourced from openFDA. This site is unofficial and independent of the FDA.