510(k) clearances

AngioVac F1885

AngioDynamics, Inc. · Cardiovascular

K263076Substantially EquivalentTraditionalDWF
Open FDA's page for this record
Third party flag
N
City
Queensbury
Advisory committee description
Cardiovascular
Address 1
603 Queensbury Ave.
Statement or summary
Summary
Product code
DWF
Zip code
12804
Applicant
AngioDynamics, Inc.
Decision date
2026-10-30
Decision code
SESE
Country code
US
Device name
AngioVac F1885
Advisory committee
CV
Contact
Sameer Mansour
K number
K263076
State
NY
Date received
2026-09-01
Review advisory committee
CV
Postal code
12804
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medical specialty description
Cardiovascular
Regulation number
870.4210
Device class
2
Registration number
3003752502, 1221051, 3007421149, 3005941719, 3009380063, 1220948, 3045042524, 3011554160, 2030598, 3017987980, 3002807090, 3031571797, 1929756, 1319639, 1718850, 3007681502, 3011427673, 3005173255, 3013267343, 1220648, 1450019, 3010155661, 1721676, 2183744, 1724474, 1928237, 1319211, 3008500478, 2024311, 9680841, 1643116, 1218444, 8010762, 3038776570, 3018503755, 3014479313, 1519227, 1820334, 2320762, 1720929 +64 more
FEI number
3003752502, 1221051, 3007421149, 1000518731, 3009380063, 1220948, 3045042524, 3002534070, 3000215273, 3011554160, 3017987980, 3031571797, 1929756, 3002807095, 1718850, 3007681502, 3011427673, 3005173255, 3013267343, 1220648, 1450019, 3010155661, 1721676, 2183744, 1928237, 1319211, 2024311, 1643116, 1218444, 3038776570, 3018503755, 3003040625, 3014479313, 1519227, 1820334, 1720929, 3030125051, 1000514656, 1000393132, 3006003617 +64 more
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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.