Atlas FDA

CORDIS ANGIOPLASTY HEMOSTASIS DEVICES

FDA 510(k) clearance K863177 · decided 1986-10-15

Clearance details

K-number
K863177
Device name
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1986-08-18
Decision date
1986-10-15
Days to decision
58 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Attachable Cath Lab Hemostasis Valve (K152528)Galt Medical Corp.2015-12-02
Passage Hemostasis Valve (K143429)Merit Medical Systems, Inc.2014-12-22
ROTATING ADAPTERS (K140475)Merit Medical Systems, Inc.2014-04-16
COLIGN (K131124)Jilin Coronado Medical , Ltd.2013-08-28
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE (K123448)Medtronic, Inc.2012-12-13
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (K122811)Medtronic, Inc.2012-10-12
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301)Vascular Solutions Zerusa , Ltd.2012-09-07
MEDLINE STOPCOCK AND MANIFOLD (K120069)Medline Industries, Inc.2012-04-03
E-PASS (K113148)Synexmed(Shenzhen)Company Limited2012-02-28
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845)Medtronic, Inc.2012-01-25
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667)Edwards Lifesciences, LLC2012-01-12

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