Atlas FDA

MODIFICATION TO ENVOY AND VISTA BRITE TIP

FDA 510(k) clearance K021593 · decided 2002-06-13

Clearance details

K-number
K021593
Device name
MODIFICATION TO ENVOY AND VISTA BRITE TIP
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
2002-05-15
Decision date
2002-06-13
Days to decision
29 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
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
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding cathete recall (Z-1330-2025)Cordis US Corp2025-03-13
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous recall (Z-0434-05)Cordis Corporation2005-01-26

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