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Company · US

Ep Technologies, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2005. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	12
DQK	Computer, Diagnostic, Programmable	1
DRQ	Amplifier And Signal Conditioner, Transducer Signal	1
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Feb 3, 2005	K043257	REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM Ep Technologies, Inc.	DRF
Apr 9, 2002	K013349	ASTRONOMER PLUS SYSTEM Ep Technologies, Inc.	DQK
Dec 7, 2000	K003452	POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D Ep Technologies, Inc.	DRF
Aug 2, 1994	K940167	DIAGNOSTIC I CATHETER Ep Technologies, Inc.	DRF
Jul 27, 1994	K940168	DIAGNOSTIC II CATHETER Ep Technologies, Inc.	DRF
Dec 16, 1993	K924109	STEEROCATH II Ep Technologies, Inc.	DRF
Dec 16, 1993	K924108	TRACFINDER II Ep Technologies, Inc.	DRF
Oct 25, 1991	K913375	TORQUE TUBE STEEROCATH(TM) Ep Technologies, Inc.	DRF
Oct 12, 1990	K903880	FRANZ(TM) STEERABLE COMBINATION CATHETER Ep Technologies, Inc.	DRF
May 7, 1990	K900765	STEEROCATH(TM) Ep Technologies, Inc.	DRF
Mar 14, 1990	K900452	QUATTRO CATHETER Ep Technologies, Inc.	DRF
Mar 13, 1990	K900553	CONSTANT CURRENT STIMULATOR MODEL 022101 Ep Technologies, Inc.	JOQ
Jun 12, 1989	K892207	FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED Ep Technologies, Inc.	DRF
Jan 13, 1989	K885252	MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 Ep Technologies, Inc.	DRQ
Jul 18, 1988	K881853	FRANZ CATHETER Ep Technologies, Inc.	DRF

Latest recalls

Date	Firm and product	Code	Linked 510(k)
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