FDA.reportPublic FDA data

NA

Primary DI
00763000812041
Brand
NA
Company
MEDTRONIC, INC.
Model
5867-3M
Device description
CAP 5867-3M STERILE MDR
Published
2025-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTDpacemaker lead Adaptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTDPacemaker Lead AdaptorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911048000MODEL 5857-3M LEAD END CAP KITMedtronic Vascular1991-04-18DTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000812041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000812041007630008120417630008120410763000812041

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead cap kitA collection of various implantable pacing lead caps designed to cover and protect the lead terminals of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure, or to isolate (cap) any lead terminals that are not used. This device provides the surgeon with a selection of various size lead caps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885672013226VV-PlugOscor Inc.DTD2026-06-01
00885672013233LV-1 PlugOscor Inc.DTD2026-06-01
00885672013240IS4/DF4 PlugOscor Inc.DTD2026-06-01
00885672011222Lead AdaptorOscor Inc.DTD2021-08-16
00763000059460NAMEDTRONIC, INC.DTD2019-05-11
10885672102453Lead AdaptorOscor Inc.DTD2017-11-27
00836559005544Lead AdaptorOscor Inc.DTD2017-11-27
00885672008352Lead AdaptorOscor Inc.DTD2017-11-27
00885672008369Lead AdaptorOscor Inc.DTD2017-11-27
00885672008260IS4/DF4 PlugOscor Inc.DTD2017-11-21
00802526497506Lead AdaptorOscor Inc.DTD2017-11-21
00802526497513Lead AdaptorOscor Inc.DTD2017-11-21
00802526497520Lead AdaptorOscor Inc.DTD2017-11-21
00802526497537Lead AdaptorOscor Inc.DTD2017-11-21
00802526505300LV-1 PlugOscor Inc.DTD2017-11-21
00802526540608VV-PlugOscor Inc.DTD2017-11-21
00885672008277Lead AdaptorOscor Inc.DTD2017-11-15
00885672008284Lead AdaptorOscor Inc.DTD2017-11-15
00885672008291VV-PlugOscor Inc.DTD2017-11-15
00885672008307VV-PlugOscor Inc.DTD2017-11-15
00885672008314LV-1 PlugOscor Inc.DTD2017-11-15
00885672008321Lead AdaptorOscor Inc.DTD2017-11-15
00885672008338Lead AdaptorOscor Inc.DTD2017-11-15
05414734506441SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
05414734506458SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
00836559004752BIS/BLV-13Oscor Inc.DTD2016-11-10
00836559006428Lead Adaptor Bipolar/UnipolarOscor Inc.DTD2016-02-25
00836559006411BLV/BIS-10Oscor Inc.DTD2015-12-29
00836559002611C/IS-10Oscor Inc.DTD2015-10-16
00836559002642M/IS-40Oscor Inc.DTD2015-10-16