Penumbra System ACE 64 and ACE 68 Reperfusion Catheters— 510(k) K152541
Substantially EquivalentPenumbra, Inc.
FDA 510(k) clearance K152541 for Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, Substantially Equivalent on 2016-01-13. 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
- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- 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.