Penumbra System (Reperfusion Catheter RED 72)
Penumbra, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Alameda
- Advisory committee description
- Cardiovascular
- Address 1
- One Penumbra Pl.
- Statement or summary
- Summary
- Product code
- NRY
- Zip code
- 94502
- Applicant
- Penumbra, Inc.
- Decision date
- 2025-02-13
- Decision code
- SESE
- Country code
- US
- Device name
- Penumbra System (Reperfusion Catheter RED 72)
- Advisory committee
- CV
- Contact
- Sindokht (Sisi) Soltanzadeh
- K number
- K242104
- State
- CA
- Date received
- 2024-07-18
- Review advisory committee
- NE
- Postal code
- 94502
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Thrombus Retriever
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- Registration number
- 3013656790, 3015550451, 3015615738, 3016678045, 3022392708, 3012543881, 3008264254, 3014498720, 2030624, 1048735, 3020954126, 3006451981, 3015453963, 3017168767, 3010079067, 3009337401, 2183828, 3008837339, 2183744, 3019807891, 3013556777, 2029214, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 1721504, 3014590707, 3013758550, 3015701715, 3021520400, 3009957947, 3009546466, 3015531723, 2024311, 3008114965, 3016591327, 3031288142 +21 more
- FEI number
- 3013656790, 3015550451, 3015615738, 3016678045, 3022392708, 3012543881, 3008264254, 3014498720, 1048735, 3020954126, 3006451981, 3015453963, 3017168767, 3010079067, 3009337401, 2183828, 3008837339, 2183744, 3019807891, 3013556777, 3007007790, 3014211783, 3008824097, 3027319104, 3008881809, 3011370111, 1721504, 3014590707, 3013758550, 3015701715, 3009024869, 3021520400, 3009957947, 3009546466, 3015531723, 2024311, 3008114965, 3016591327, 3004099094, 3014590708 +21 more