VIEWPOINT TELEMETRY SYSTEM— 510(k) K031760
Substantially EquivalentDatascope Corp.
FDA 510(k) clearance K031760 for VIEWPOINT TELEMETRY SYSTEM, Substantially Equivalent on 2003-10-10. Applicant: Datascope Corp.. Device class: 2.
Clearance details
- Applicant
- Datascope Corp.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mahwh, NJ, US
Recent devices under product code MHX
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- 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
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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 K031760
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031760.
Data sourced from openFDA. This site is unofficial and independent of the FDA.