Vascoscrew 6/60 and Vascoscrew 8/60

FDA 510(k) K914121 · Vascor Medical Corp.

Substantially Equivalent

510(k) numberK914121

Submission

Device name
Vascoscrew 6/60 and Vascoscrew 8/60
Applicant
Vascor Medical Corp.
Tarpon Springs, FL, US
Received
September 13, 1991
Decision date
August 24, 1993
Decision
Substantially Equivalent (SESE)
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
K920662Vascotwist 9/60DTB · Traditional 11/24/1993SESP
K913831Vasco Tip/VascoflangeDTB · Traditional 08/25/1993SE

Questions and answers

When was Vascoscrew 6/60 and Vascoscrew 8/60 cleared by the FDA?

Vascoscrew 6/60 and Vascoscrew 8/60 (K914121) received a 510(k) decision of Substantially Equivalent on August 24, 1993, 711 days after the submission was received.

What is the product code of K914121?

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