Atlas FDA

CHRONOCOR IV MODEL 250

FDA 510(k) clearance K802221 · decided 1980-11-19

Clearance details

K-number
K802221
Device name
CHRONOCOR IV MODEL 250
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1980-09-12
Decision date
1980-11-19
Days to decision
68 days
Clearance type
Traditional
Product code
DTE
Device class
2
Regulation number
870.3600
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Medtronic Temporary External Pacemaker 53401 (K162054)Medtronic, Inc.2016-10-18
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Recalls involving this device

No recalls on record reference this clearance.

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