Cardifix Endocardial Pacing Lead

FDA 510(k) K922042 · Intermedics, Inc.

Unknown

510(k) numberK922042

Submission

Device name
Cardifix Endocardial Pacing Lead
Applicant
Intermedics, Inc.
Angleton, TX, US
Received
May 1, 1992
Decision date
April 29, 1993
Decision
Unknown (SESP)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTB – Permanent Pacemaker Electrode
Device class
Class III (high risk)
Regulation
21 CFR 870.3680
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code DTB

510(k)DeviceApplicantDecision
K061212Biotronik Endocardial Pacing LeadsDTB · Special Biotronik, Inc.07/10/2006SE
K041809Permanent Pacing Lead, Model PY2DTB · Special Oscor, Inc.08/06/2004SE
K040569Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, RjuDTB · Special Oscor, Inc.04/07/2004SE
K031274Model 5071 Myocardial Pacing LeadDTB · Special Medtronic Vascular05/22/2003ST
K031210Model 4951M Myocardial Unipolar LeadDTB · Special Metronic, Inc.05/16/2003SE
K023205Elox P 45-BP; Elox P 53-BP; Elox P 60-BPDTB · Traditional Biotronik, Inc.04/24/2003ST
K024053Permanent Pacing Leads, Models Physique PB and PJBDTB · Special Oscor, Inc.01/31/2003SE
K023803Modification to Biotronik's Sterilization ProcessDTB · Special Biotronik, Inc.12/11/2002SE
K023099Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special Biotronik, Inc.10/18/2002SE
K021217Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special Biotronik, Inc.05/01/2002SE

More from Biotronik, Inc.

510(k)DeviceDecision
K954610Model 430-07 Endocardial Pacing LeadDTB · Traditional 12/16/1996PT
K955122Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional 11/04/1996ST
K962174Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional 08/21/1996ST
K955550Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional 06/19/1996ST
K960281Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional 06/18/1996ST
K954719Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional 02/27/1996ST
K933278Intermedics Triangle Chest Probe Model 526-04KRG · Traditional 03/15/1995SE
K922972Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional 01/22/1993SESP
K920530Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional 03/17/1992SE
K912235Models 432-03 & 433-03 Implant Endocard Pac LeadDTB · Traditional 09/18/1991SE

Questions and answers

When was Cardifix Endocardial Pacing Lead cleared by the FDA?

Cardifix Endocardial Pacing Lead (K922042) received a 510(k) decision of Unknown on April 29, 1993, 363 days after the submission was received.

What is the product code of K922042?

The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.