Atlas FDA

VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015

FDA 510(k) clearance K860149 · decided 1986-03-31

Clearance details

K-number
K860149
Device name
VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015
Applicant
Dlp, Inc.
Decision
Substantially Equivalent
Date received
1986-01-15
Decision date
1986-03-31
Days to decision
75 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Grand Rapids, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardi recall (Z-2214-2026)Medtronic Perfusion Systems2026-05-20
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardi recall (Z-2215-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopu recall (Z-2216-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopul recall (Z-2217-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopul recall (Z-2218-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopul recall (Z-2219-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopu recall (Z-2220-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopul recall (Z-2221-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopul recall (Z-2222-2026)Medtronic Perfusion Systems2026-05-20