CARDIO-COOL— 510(k) K860523
Substantially EquivalentBio-Vascular, Inc.
FDA 510(k) clearance K860523 for CARDIO-COOL, Substantially Equivalent on 1986-04-29. Applicant: Bio-Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Vascular, 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
- St. Paul, MN, US
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More clearances from Bio-Vascular, Inc.
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- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
Adverse 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.