Implantable Pacing Lead, Tined #3262 &

FDA 510(k) K823447 · Vascular Products, Inc.

Substantially Equivalent

510(k) numberK823447

Submission

Device name
Implantable Pacing Lead, Tined #3262 &
Applicant
Vascular Products, Inc.
Walker, MI, US
Received
November 16, 1982
Decision date
December 3, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K913733Sterile Chest TubeGBW · Traditional 10/08/1991SE
K910840Vascular Biopsy ForcepsDWZ · Traditional 07/15/1991SE

Questions and answers

When was Implantable Pacing Lead, Tined #3262 & cleared by the FDA?

Implantable Pacing Lead, Tined #3262 & (K823447) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 17 days after the submission was received.

What is the product code of K823447?

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