Atlas FDA

FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE

FDA 510(k) clearance K974067 · decided 1998-02-27

Clearance details

K-number
K974067
Device name
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
Applicant
Merit Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1997-10-27
Decision date
1998-02-27
Days to decision
123 days
Clearance type
Traditional
Product code
QEY
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
South Jordan, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0872-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0873-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-90-20-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0874-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-90-10-038, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0875-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0876-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0877-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0878-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0879-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0880-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0881-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-45-10-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0882-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0883-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO, Merit Medical Systems, Inc., South recall (Z-0884-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO, Merit Medical Systems, Inc., Sout recall (Z-0885-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO, Merit Medical Systems, Inc., Sout recall (Z-0886-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO, Merit Medical Systems, Inc., Sout recall (Z-0887-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO, Merit Medical Systems, Inc., Sout recall (Z-0888-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, K12-MIC13510, Sterile EO, Merit Medical Systems, Inc., South J recall (Z-0889-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, K12-MIC13505, Sterile EO, Merit Medical Systems, Inc., South J recall (Z-0890-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, K12-MIC09010, Sterile EO, Merit Medical Systems, Inc., South J recall (Z-0891-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South J recall (Z-0892-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, K12-MIC04510, Sterile EO, Merit Medical Systems, Inc., South J recall (Z-0893-2010)Merit Medical Systems, Inc.2010-03-02
Mistique Infusion Catheter, K12-MIC04505, Sterile EO, Merit Medical Systems, Inc., South J recall (Z-0894-2010)Merit Medical Systems, Inc.2010-03-02

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