510(k) clearances

Gravity Blood Sets with 200µm Filter

B.Braun Medical, Inc. · General Hospital

K260261Substantially EquivalentTraditionalFPA
Open FDA's page for this record
Third party flag
N
City
Bethlehem
Advisory committee description
General Hospital
Address 1
824 12th Ave.
Statement or summary
Summary
Product code
FPA
Zip code
18018
Applicant
B.Braun Medical, Inc.
Decision date
2026-10-22
Decision code
SESE
Country code
US
Device name
Gravity Blood Sets with 200µm Filter
Advisory committee
HO
Contact
Stacia Preston
K number
K260261
State
PA
Date received
2026-01-28
Review advisory committee
HO
Postal code
18018
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Set, Administration, Intravascular
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2
Registration number
3003700453, 8021545, 3009456923, 1000523114, 3002806603, 2029015, 3016472589, 3012302888, 3011944170, 9617592, 9611590, 3006425876, 1314417, 3013696225, 3004111573, 3043226252, 3033589330, 3003974574, 9681835, 1000587249, 3044994889, 3044026004, 1833470, 2437459, 2523676, 9610825, 1410248, 3012116434, 3015060216, 3005515211, 8020040, 2025816, 3012187973, 9680425, 3010413216, 3003895440, 3003442380, 3007363456, 3014162214, 3009976527 +390 more
FEI number
3003700453, 1000113359, 3009456923, 1000523114, 3002806603, 3016472589, 3000974732, 3012302888, 1000208624, 1000120555, 3011944170, 3006425876, 1314417, 3013696225, 3932, 3004111573, 3043226252, 3033589330, 3003974574, 1000587249, 3044994889, 3044026004, 3002826093, 3003166194, 2523676, 1410248, 3012116434, 3015060216, 3005515211, 3000147578, 2025816, 3012187973, 3002879021, 3010413216, 3003895440, 1000226372, 3003442380, 3000204695, 3003040625, 3014162214 +390 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.