510(k) K222808
- Device
- Penumbra System (Reperfusion Catheter RED 43)
- Applicant
- Penumbra, Inc.
- 510(k) number
- K222808
- Product code
- NRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-20
- Date received
- 2022-09-16
- Regulation
- 870.1250
- Classification name
- Catheter, Thrombus Retriever
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Micaela Victoria
- Address
- One Penumbra Pl. Alameda CA US 94502 94502
FDA Registration Numbers
- 3017168767
- 3002807314
- 3007628272
- 3012931345
- 1048735
- 2024311
- 3003144120
- 3014211783
- 3014644549
- 3011370111
- 3014162263
- 3008881809
- 3008837339
- 3031288142
- 3021009035
- 3021520400
- 9616664
- 3016540856
- 3014590707
- 2030624
- 3013656790
- 3030088112
- 3015453963
- 3012543881
- 2183744
- 3013758550
- 3005168196
- 3014498720
- 3007007790
- 3009957947
- 3022392708
- 3016522967
- 3016678045
- 2029214
- 3012497308
- 3014590708
- 3016591327
- 3015550451
- 1220477
- 3008824097
- 2183828
- 3015615738
- 3010034260
- 3008264254
- 3009337401
- 3013556777
- 2011171
- 3009380063
- 3015531723
- 3019807891
- 3008853977
- 1721676
- 1721504
- 3015701715
- 3009546466
- 3006451981
- 3008114965
- 3010079067
- 3020954126
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