IAB ANCHOR— 510(k) K922103
Substantially EquivalentDatascope Corp.
FDA 510(k) clearance K922103 for IAB ANCHOR, Substantially Equivalent on 1993-08-03. Applicant: Datascope Corp.. Device class: 1.
Clearance details
- Applicant
- Datascope Corp.
- Product code
- Code KMK
- Device class
- Class 1
- Regulation
- 21 CFR 880.5210
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, NJ, US
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Adverse events under product code KMK
product code KMK- Malfunction
- 461
- Other
- 1
- Total
- 462
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.