COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS— 510(k) K000977
Substantially EquivalentOlson Medical Sales, Inc.
FDA 510(k) clearance K000977 for COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS, Substantially Equivalent on 2001-03-23. Applicant: Olson Medical Sales, Inc.. Device class: 2.
Clearance details
- Applicant
- Olson Medical Sales, Inc.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkton, MD, US
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More clearances from Olson Medical Sales, Inc.
view allAdverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
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.