510(k) K112892
- Device
- IMPELLA 2.5 PLUS CATHETER
- Applicant
- ABIOMED, INC.
- 510(k) number
- K112892
- Product code
- PBL
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2012-09-06
- Date received
- 2011-09-30
- Regulation
- 870.4360
- Classification name
- Temporary Cardiac Support Blood Pump
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLYN PEKAR
- Address
- 22 Cherry Hill Dr. Danvers MA US 01923 01923
FDA Registration Numbers#
- 2528981
Source Documents#
Legacy Summary#
summary
FDA Review#
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