CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump— 510(k) K172305
Substantially EquivalentDatascope Corp.
FDA 510(k) clearance K172305 for CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump, Substantially Equivalent on 2017-10-12. 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
Recent devices under product code DSP
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view all- K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
- K181122 — CARDIOSAVE 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
- K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
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 K172305
K-number listed on FDA's recall record- Z-1486-2026 — CS100 IABP. Software Version CS100 IABP Q.01.
- Z-1487-2026 — CS300 IABP. Software Version CS300 IABP C.01.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172305.
Data sourced from openFDA. This site is unofficial and independent of the FDA.