Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set— 510(k) K162181
Substantially EquivalentCardiacassist, Inc.
FDA 510(k) clearance K162181 for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set, Substantially Equivalent on 2017-01-06. Applicant: Cardiacassist, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiacassist, Inc.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code DRE
view allMore clearances from Cardiacassist, Inc.
view allAdverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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 K162181
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 K162181.
Data sourced from openFDA. This site is unofficial and independent of the FDA.