Atlas FDA

INFANT VENT CATHETER 12001 W/SIDE VENT

FDA 510(k) clearance K834039 · decided 1984-01-03

Clearance details

K-number
K834039
Device name
INFANT VENT CATHETER 12001 W/SIDE VENT
Applicant
Dlp, Inc.
Decision
Substantially Equivalent
Date received
1983-11-23
Decision date
1984-01-03
Days to decision
41 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
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13 recall (Z-2480-2025)Medtronic Perfusion Systems2025-09-03
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10 recall (Z-2481-2025)Medtronic Perfusion Systems2025-09-03
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15 recall (Z-2482-2025)Medtronic Perfusion Systems2025-09-03