Biotronik, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 20, 2004

ERA 3000 PACING SYSTEM ANALYZER

K042708 · DTE

Cardiovascular · 20d

Cleared Dec 08, 2003

MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

K033613 · DTA

Cardiovascular · 21d

Cleared Nov 19, 2003

SCOUT PRO

K033320 · DQY

Cardiovascular · 35d

Cleared Oct 31, 2003

PHERON PTA CATHETER

K033217 · DQY

Cardiovascular · 28d

Cleared Apr 24, 2003

ELOX P 45-BP

K023205 · DTB

Cardiovascular · 211d

Cleared Jan 27, 2003

ERA 3000

K022360 · DTA

Cardiovascular · 192d

Cleared Dec 11, 2002

MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS

K023803 · DTB

Cardiovascular · 27d

Cleared Oct 18, 2002

AROX 45-JBP

K023099 · DTB

Cardiovascular · 30d

Cleared Jun 03, 2002

SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117

K020821 · DQX

Cardiovascular · 82d

Cleared May 01, 2002

AROX 53-BP

K021217 · DTB

Cardiovascular · 14d

Cleared Apr 09, 2002

MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP

K010281 · DTB

Cardiovascular · 434d

Cleared Jan 18, 2001

A1-CS-SB Y-ADAPTER, MODEL 124 871

K003454 · DTD

Cardiovascular · 72d

Cleared Jan 09, 2001

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

K003072 · DTB

Cardiovascular · 98d

Cleared Aug 02, 2000

GALEO HYDRO AND GALEO HYDRO J-TIP

K001736 · DQX

Cardiovascular · 56d

Cleared Jun 02, 2000

ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668

K001413 · DTB

Cardiovascular · 29d

Cleared Apr 13, 2000

EX 45-BP, MODEL 330 132

K994240 · DTB

Cardiovascular · 119d

Cleared Dec 17, 1999

YP 45/15-BP

K993139 · DTB

Cardiovascular · 88d

Cleared Nov 10, 1999

PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A

K993434 · DXY

Cardiovascular · 29d

Cleared Jul 01, 1999

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854

K991169 · DTB

Cardiovascular · 85d

Cleared Jun 03, 1999

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

K990483 · DTB

Cardiovascular · 107d

Cleared Jan 08, 1999

GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL...

K982272 · DQX

Cardiovascular · 193d

Cleared Sep 10, 1998

SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120...

K980869 · DTB

Cardiovascular · 188d

Cleared Jul 22, 1998

RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL...

K981083 · DTB

Cardiovascular · 120d

Not Cleared Mar 04, 1998

TIR/TIJ AND POLYROX

K972500 · DTB

Cardiovascular · 244d

Not Cleared Jan 27, 1998

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

K965106 · DTB

Cardiovascular · 403d