Impella 2.5 Plus Catheter
FDA 510(k) K112892 · Abiomed, Inc.
510(k) numberK112892
Submission
- Device name
- Impella 2.5 Plus Catheter
- Applicant
- Abiomed, Inc.
Danvers, MA, US - Received
- September 30, 2011
- Decision date
- September 6, 2012
- Decision
- Unknown (SESU)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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Questions and answers
When was Impella 2.5 Plus Catheter cleared by the FDA?
Impella 2.5 Plus Catheter (K112892) received a 510(k) decision of Unknown on September 6, 2012, 342 days after the submission was received.