Atlas FDA

PACEMAKER LEAD ADAPTER

FDA 510(k) clearance K862656 · decided 1986-07-30

Clearance details

K-number
K862656
Device name
PACEMAKER LEAD ADAPTER
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1986-07-14
Decision date
1986-07-30
Days to decision
16 days
Clearance type
Traditional
Product code
DTD
Device class
2
Regulation number
870.3620
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
IS4/DF4 Port Plug (K143463)Oscor, Inc.2015-03-19
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP (K132008)Medtronic, Inc.2013-07-30
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (K041574)Guidant Corporation2004-07-12
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (K031164)Oscor, Inc.2003-06-19
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR (K024156)Oscor, Inc.2003-01-14
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787)Oscor, Inc.2001-05-22
A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454)Biotronik, Inc.2001-01-18
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210)Medtronic Vascular2000-02-23
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (K982220)Medtronic Vascular1998-10-15
BK-N SEALING CAP (K971930)Biotronik, Inc.1997-08-14
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388)Biotronik, Inc.1997-08-14
BK-A; BK-B; BK-IS SEALING CAP (K970204)Biotronik, Inc.1997-04-29

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