510(k) clearances

Vertex™ Thrombectomy System

Jupiter Endovascular · Cardiovascular

K261523Substantially EquivalentTraditionalQEW
Open FDA's page for this record
Third party flag
N
City
Menlo Park
Advisory committee description
Cardiovascular
Address 1
155 Jefferson Dr.
Statement or summary
Summary
Product code
QEW
Zip code
94025
Applicant
Jupiter Endovascular
Decision date
2026-08-04
Decision code
SESE
Country code
US
Device name
Vertex™ Thrombectomy System
Advisory committee
CV
Contact
Nicole Barber
K number
K261523
State
CA
Date received
2026-05-07
Review advisory committee
CV
Postal code
94025
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Peripheral Mechanical Thrombectomy With Aspiration
Medical specialty description
Cardiovascular
Regulation number
870.5150
Device class
2
Registration number
3010034260, 1225687, 3019807891, 3026567963, 3009380063, 3013944123, 3029444898, 3017210488, 3020256033, 3004198398, 1644312, 3010273872, 3040801290, 3010220595, 3010047454, 1000121056, 1724474, 1424778, 3010041511, 3004111573, 3002807314, 3015615738, 3016704395, 3031823122, 3017823876, 3011642792, 3008700817, 2124215, 3008514120, 9681260, 3007695959, 3005160949, 1625425, 3011137372, 3008114965, 1000523114, 3011471056, 1721676, 3025465918, 3008439199 +34 more
FEI number
3010034260, 3019807891, 3026567963, 3009380063, 3013944123, 3029444898, 3017210488, 3020256033, 3004198398, 3010273872, 3040801290, 3010220595, 3010047454, 1000121056, 3004593495, 3015615738, 3010041511, 3004111573, 3002807314, 3016704395, 3001451463, 3031823122, 3017823876, 3011642792, 3008700817, 2124215, 3008514120, 3003058448, 1000117748, 3007695959, 3003094851, 3005160949, 1625425, 3008114965, 1000523114, 3011471056, 1721676, 3025465918, 3008439199, 3031976597 +34 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.

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.