Atlas FDA

STOPCOCKS, MANIFOLDS

FDA 510(k) clearance K782095 · decided 1979-01-23

Clearance details

K-number
K782095
Device name
STOPCOCKS, MANIFOLDS
Applicant
Namic
Decision
Substantially Equivalent
Date received
1978-12-18
Decision date
1979-01-23
Days to decision
36 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary recall (Z-2138-2026)Medline Industries, LP2026-05-08
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary recall (Z-2139-2026)Medline Industries, LP2026-05-08
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary recall (Z-2140-2026)Medline Industries, LP2026-05-08
NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk recall (Z-0287-2009)Navilyst Medical2008-11-09
''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University recall (Z-1393-05)Boston Scientific Corp2005-08-24