3M CDI QUICK-CELLS WITH HEPARIN TREATMENT— 510(k) K980732
Substantially Equivalent3M Healthcare
FDA 510(k) clearance K980732 for 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT, Substantially Equivalent on 1998-05-15. Applicant: 3M Healthcare. Device class: 2.
Clearance details
- Applicant
- 3M Healthcare
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tistin, CA, US
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Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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.