Atlas FDA

CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS

FDA 510(k) clearance K974083 · decided 1998-01-13

Clearance details

K-number
K974083
Device name
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
Applicant
Ohmeda Medical
Decision
Substantially Equivalent
Date received
1997-10-29
Decision date
1998-01-13
Days to decision
76 days
Clearance type
Traditional
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Murray Hill, NJ, 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
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcock recall (Z-2514-2026)BD SWITZERLAND SARL2026-06-18
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and Co recall (Z-1509-2025)BD SWITZERLAND SARL2025-04-02