Penumbra System (Reperfusion Catheter RED 72)— 510(k) K211654
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K211654 for Penumbra System (Reperfusion Catheter RED 72), Substantially Equivalent on 2021-08-16. Applicant: Penumbra, Inc.. Device class: 2.
Clearance details
- Applicant
- Penumbra, Inc.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
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More clearances from Penumbra, Inc.
view all- K262904 — INDIGO® Aspiration System
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- K260599 — INDIGO® Aspiration System INDIGO Link
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
Adverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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.