Implant Aid Splicing Crimp & Sleeve

FDA 510(k) K813518 · Intermedics, Inc.

Substantially Equivalent

510(k) numberK813518

Submission

Device name
Implant Aid Splicing Crimp & Sleeve
Applicant
Intermedics, Inc.
Mchenry, IL, US
Received
December 16, 1981
Decision date
January 12, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KFJ – Materials, Repair Or Replacement, Pacemaker
Device class
Class III (high risk)
Regulation
21 CFR 870.3710
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code KFJ

510(k)DeviceApplicantDecision
K913919Universal Terminal Cap, 3.2MMKFJ · Traditional Telectronics Pacing Systems, Inc.12/31/1991SE
K852236Medtronic Model 5867-1AKFJ · Traditional Medtronic Vascular07/11/1985SE

More from Medtronic Vascular

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
K922042Cardifix Endocardial Pacing LeadDTB · Traditional 04/29/1993SESP
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

Questions and answers

When was Implant Aid Splicing Crimp & Sleeve cleared by the FDA?

Implant Aid Splicing Crimp & Sleeve (K813518) received a 510(k) decision of Substantially Equivalent on January 12, 1982, 27 days after the submission was received.

What is the product code of K813518?

The FDA product code is KFJ – Materials, Repair Or Replacement, Pacemaker, a Class III (high risk) device regulated under 21 CFR 870.3710.