510(k) clearances

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device

Phenox Limited · Neurology

K242676Substantially EquivalentSpecialPOL
Open FDA's page for this record
Third party flag
N
City
Galway
Advisory committee description
Neurology
Address 1
Kamrick Ct.
Address 2
Ballybrit Business Park
Statement or summary
Summary
Product code
POL
Zip code
H91XY38
Applicant
Phenox Limited
Decision date
2025-02-28
Decision code
SESE
Country code
IE
Device name
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
Advisory committee
NE
Contact
Rachel McDaid
K number
K242676
Date received
2024-09-06
Review advisory committee
NE
Postal code
H91XY38
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Medical specialty description
Neurology
Regulation number
882.5600
Device class
2
Registration number
3013656790, 3015550451, 3012497308, 2029214, 3007007790, 3008853977, 3031288142, 3012931345, 3006451981, 3016540856, 1721676, 2011171, 3009380063
FEI number
3013656790, 3015550451, 3012497308, 3007007790, 1000220862, 3008853977, 3031288142, 3012931345, 3006451981, 3016540856, 1721676, 2011171, 3009380063
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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.