Atlas FDA

VACLOK SYRINGE

FDA 510(k) clearance K994253 · decided 2000-01-05

Clearance details

K-number
K994253
Device name
VACLOK SYRINGE
Applicant
Merit Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1999-12-17
Decision date
2000-01-05
Days to decision
19 days
Clearance type
Special
Product code
FMF
Device class
2
Regulation number
880.5860
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
South Jordan, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., S recall (Z-0503-2011)Merit Medical Systems, Inc.2010-12-02
VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., recall (Z-0504-2011)Merit Medical Systems, Inc.2010-12-02
Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical System recall (Z-0505-2011)Merit Medical Systems, Inc.2010-12-02
Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical System recall (Z-0506-2011)Merit Medical Systems, Inc.2010-12-02
EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients und recall (Z-0307-04)Heartport Inc2004-01-09
EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients und recall (Z-0308-04)Heartport Inc2004-01-09
DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary by recall (Z-0309-04)Heartport Inc2004-01-09
SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary recall (Z-0310-04)Heartport Inc2004-01-09
Introducer Sheath is indicated for patients requiring introduction of catheters. Introduce recall (Z-0311-04)Heartport Inc2004-01-09
VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER recall (Z-0139-04)Merit Medical Systems, Inc2003-11-19

PMA approvals by this applicant

RecordFirmDate
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004)Merit Medical Systems, Inc.2025-12-11
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001)Merit Medical Systems, Inc.2025-02-12
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002)Merit Medical Systems, Inc.2025-02-12
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023)Merit Medical Systems, Inc.2024-12-19