FDA.reportPublic FDA data

C/IS-10

Primary DI
00836559002611
Brand
C/IS-10
Company
Oscor Inc.
Model
C/IS-10
Catalog number
C/IS-10
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K925168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925168000MISCELLANEOUS PACING LEADOscor Medical Corp.1994-05-03DTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836559002611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836559002611008365590026118365590026110836559002611

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101835833
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885672009882SafeSheath® IISSC9SSC92020-08-06
10885672009899SafeSheath® IISSCL9SSCL92020-08-06
10885672012691SafeSheath® IISSCL9SSCL92024-10-28
20885672012636SafeSheath® IISSL9030SSL90302024-07-17
20885672012643SafeSheath® IISSL9040SSL90402024-07-17
30885672010059Transvalvular Insertion Tool (TVI)667612-100667612-1002020-09-30
00885672009731Introducer Kit for Impella®0052-30010052-30012019-09-24
00885672009748Introducer Kit for Impella®0052-30000052-30002019-09-24
00885672009755Introducer Kit for Impella®0052-30060052-30062019-09-24
00885672009762Introducer Kit for Impella®0052-30140052-30142019-09-24
00885672009779Introducer Kit for Impella®0052-30150052-30152019-09-24
00885672009786Introducer Kit for Impella®0052-30210052-30212019-09-24
00885672009793Introducer Kit for Impella®0052-30250052-30252019-09-24
00836559006732Adelante Peel-Away Introducer SetAP07016AP070162017-11-15
00836559006770Adelante Peel-Away Introducer SetAP09016AP090162017-11-15
00836559006794Adelante Peel-Away Introducer SetAP10016AP100162017-11-15
00836559006800Adelante Peel-Away Introducer SetAP10516AP105162017-11-15
00836559007050Adelante SigmaASGAT110162017-12-07
10836559007385Adelante SigmaASG050102017-11-16
10836559007392Adelante SigmaASG060102017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885672013189Lead AdaptorOscor Inc.DTD2026-07-24
00885672013196Lead AdaptorOscor Inc.DTD2026-07-24
00885672013202Lead AdaptorOscor Inc.DTD2026-07-24
00885672013219Lead AdaptorOscor Inc.DTD2026-07-24
00885672013226VV-PlugOscor Inc.DTD2026-06-01
00885672013233LV-1 PlugOscor Inc.DTD2026-06-01
00885672013240IS4/DF4 PlugOscor Inc.DTD2026-06-01
00763000812041NAMEDTRONIC, INC.DTD2025-04-12
00885672011222Lead AdaptorOscor Inc.DTD2021-08-16
00763000059460NAMEDTRONIC, INC.DTD2019-05-11
00813502011517Introducer Kit for Impella®Oscor Inc.DTD2017-11-30
00813502011562Introducer Kit for Impella®Oscor Inc.DTD2017-11-30
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
00813502011609Introducer Kit for Impella®Oscor Inc.DTD2017-11-19
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