510(k) clearances

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Perfuze, Ltd. · Cardiovascular

K250012Substantially EquivalentSpecialNRY
Open FDA's page for this record
Third party flag
N
City
Galway
Advisory committee description
Cardiovascular
Address 1
Unit 6, Galway Business Park
Address 2
Dangan
Statement or summary
Summary
Product code
NRY
Zip code
H91W7CP
Applicant
Perfuze, Ltd.
Decision date
2025-02-26
Decision code
SESE
Country code
IE
Device name
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Advisory committee
CV
Contact
Anne-Marie Gannon
K number
K250012
Date received
2025-01-02
Review advisory committee
NE
Postal code
H91W7CP
Decision description
Substantially Equivalent
Clearance type
Special
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
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.