Atlas FDA

5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER

FDA 510(k) clearance K970854 · decided 1997-09-30

Clearance details

K-number
K970854
Device name
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1997-03-10
Decision date
1997-09-30
Days to decision
204 days
Clearance type
Traditional
Product code
DQO
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Miami Lakes, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac cath recall (Z-0286-2024)Cordis US Corp2023-11-09
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector t recall (Z-0720-2023)Cordis US Corp2022-12-16
Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, recall (Z-1240-06)Cordis Corporation2006-07-13

PMA approvals by this applicant

RecordFirmDate
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086)Cordis Corp.2014-10-10
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082)Cordis Corp.2012-01-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085)Cordis Corp.2012-01-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059)Cordis Corp.2011-05-27
CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083)Cordis Corp.2011-05-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081)Cordis Corp.2011-03-03
CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026)Cordis Corp.2011-02-22
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02