FDA.reportPublic FDA data

Adelante Peel-Away Introducer Set

Primary DI
00836559006732
Brand
Adelante Peel-Away Introducer Set
Company
Oscor Inc.
Model
AP07016
Catalog number
AP07016
Device description
Peel-Away Introducer Set, 7F
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073100000INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-SOscor, Inc.2007-11-30DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836559006732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836559006732008365590067328365590067320836559006732

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter0
Needle Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(727)937-2511sales@oscor.com

Regulatory Flags#

DUNS number
101835833
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
10885672000025Adelante SafeSheath Ultra LiteASUP131318PASUP131318P2017-11-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00389701011974GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
00389701011981GLIDESHEATH SLENDERTERUMO MEDICAL CORPORATIONDYB2018-05-23
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00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
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