510(k) clearances

Impress Angiographic Catheter

Merit Medical Systems, Inc. · Cardiovascular

K233268Substantially EquivalentSpecialDQO
Open FDA's page for this record
Third party flag
N
City
South Jordan
Advisory committee description
Cardiovascular
Address 1
1600 W. Merit Pkwy.
Statement or summary
Summary
Product code
DQO
Zip code
84095
Applicant
Merit Medical Systems, Inc.
Decision date
2024-05-22
Decision code
SESE
Country code
US
Device name
Impress Angiographic Catheter
Advisory committee
CV
Contact
Gamaliel Figueroa
K number
K233268
State
UT
Date received
2023-09-29
Review advisory committee
CV
Postal code
84095
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Catheter, Intravascular, Diagnostic
Medical specialty description
Cardiovascular
Regulation number
870.1200
Device class
2
Registration number
3013656790, 2648045, 3009600098, 3030446844, 9616088, 9617594, 3004122598, 3012159165, 3002991496, 3004737415, 1317547, 1000523114, 3019807891, 9616683, 3007138831, 3012766489, 1061124, 1055236, 3006425876, 3030714660, 3031571797, 1035166, 2134812, 2024168, 3008114965, 8043983, 3004111573, 3033589330, 3011137372, 3013764800, 2246552, 3012497308, 9680794, 1625425, 3006985147, 8010026, 3023245, 2523676, 3004091615, 3012198618 +171 more
FEI number
3013656790, 2648045, 3009600098, 3030446844, 2828, 3004122598, 3002806565, 3012159165, 3002991496, 3004737415, 1317547, 1000523114, 3019807891, 3016261803, 1000208624, 3007138831, 3012766489, 3003094575, 3006425876, 3002806901, 3030714660, 3031571797, 1035166, 2024168, 3008114965, 3004111573, 3033589330, 3000206435, 3001236905, 3003081151, 3013764800, 3002565916, 2246552, 3012497308, 3002913962, 1625425, 1000220862, 3002806476, 3023245, 3006985147 +170 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.