510(k) clearances

70 NeuGlide Catheter

Piraeus Medical, Inc. · Cardiovascular

K262277Substantially EquivalentSpecialQJP
Open FDA's page for this record
Third party flag
N
City
Maple Grove
Advisory committee description
Cardiovascular
Address 1
7351 Kirkwood Ln. N, Suite 116
Statement or summary
Summary
Product code
QJP
Zip code
55369
Applicant
Piraeus Medical, Inc.
Decision date
2026-09-04
Decision code
SESE
Country code
US
Device name
70 NeuGlide Catheter
Advisory committee
CV
Contact
Sarah Kabanuk
K number
K262277
State
MN
Date received
2026-07-06
Review advisory committee
NE
Postal code
55369
Decision description
Substantially Equivalent
Clearance type
Special
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.