510(k) clearances

Zoom 4S Catheter

Imperative Care, Inc. · Cardiovascular

K261176Substantially EquivalentTraditionalQJP
Open FDA's page for this record
Third party flag
N
City
Campbell
Advisory committee description
Cardiovascular
Address 1
1359 Dell Ave.
Statement or summary
Summary
Product code
QJP
Zip code
95008
Applicant
Imperative Care, Inc.
Decision date
2026-08-28
Decision code
SESE
Country code
US
Device name
Zoom 4S Catheter
Advisory committee
CV
Contact
Peter Taylor
K number
K261176
State
CA
Date received
2026-04-10
Review advisory committee
NE
Postal code
95008
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Percutaneous, Neurovasculature
Medical specialty description
Cardiovascular
Regulation number
870.1250
Device class
2
Registration number
3047894544, 3019807891, 3017278832, 3024801436, 3009380063, 3013944123, 3016800412, 3017210488, 2027062, 3016522967, 3007628272, 3039020025, 2024311, 3000308637, 1047843, 3003780911, 3015615738, 3002807314, 3015550451, 3014644549, 3031768596, 3008824097, 3006451981, 1220477, 1721686, 9612501, 3014162263, 3014758755, 3032047719, 3007007790, 3008853977, 3008114965, 3011370111, 1064858, 1721676, 3009337401, 3030088112, 3012931345, 2183744, 3008837339 +36 more
FEI number
3047894544, 3019807891, 3017278832, 3024801436, 3009380063, 3013944123, 3016800412, 3017210488, 2027062, 3016522967, 3007628272, 3039020025, 2024311, 3000308637, 1047843, 3003780911, 3015615738, 3002807314, 3015550451, 3014644549, 3031768596, 3008824097, 3006451981, 1220477, 1721686, 3014162263, 3014758755, 3032047719, 3007007790, 3008853977, 3008114965, 3011370111, 1721676, 3009337401, 3030088112, 3012931345, 2183744, 3008837339, 3012497308, 3008264254 +36 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.