FDA.reportPublic FDA data

CPS AIM™

Primary DI
05415067041777
Brand
CPS AIM™
Company
ST. JUDE MEDICAL, INC.
Model
DS2N101-59
Catalog number
DS2N101-59
Device description
Universal II Slittable Inner Catheter (Subselector)
Published
2022-10-20
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
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221750000CPS AIM Universal II Slittable Inner CatheterABBOTT MEDICAL2022-06-30DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067041777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067041777054150670417775415067041777

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length59Centimeter
Outer Diameter2.46Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Storage excursions permitted from 15°- 25° C (59°- 77°F)
Storage Environment Temperature20 Degrees Celsius20 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit68 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067033307Amplatzer™ Talisman™9-PFO-18189-PFO-18182021-09-29
05415067033314Amplatzer™ Talisman™9-PFO-25189-PFO-25182021-09-29
05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
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06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
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06934955914850Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914867Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914874Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914881Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914898Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914904Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914911Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914928Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
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