FDA.reportPublic FDA data

Phenom™ Catheter

Primary DI
00814584021340
Brand
Phenom™ Catheter
Company
CATHERA, INC.
Model
FG11150-0615-2RV01
Catalog number
FG11150-0615-2R
Device description
Phenom™ 17 Catheter
Published
2016-10-20
Public version status
Update
Distribution status
Not 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
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151638000Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.2015-11-13DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814584021340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814584021340008145840213408145840213400814584021340

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Centimeter
Lumen/Inner Diameter0.017Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dark, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-949-837-3700cerreport@covidien.com

Regulatory Flags#

DUNS number
080116681
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814584020381Phenom™ CatheterFG11150-0615-2SV01FG11150-0615-2S2016-10-20
00814584020398Phenom™ CatheterFG11150-1015-2SV01FG11150-1015-2S2016-10-20
00814584020435Phenom™ CatheterFG11170-0615-2SV01FG11170-0615-2S2016-10-20
00814584020442Phenom™ CatheterFG11170-1015-2SV01FG11170-1015-2S2016-10-20
00814584020862Phenom™ CatheterFG11150-0615-2XV01FG11150-0615-2X2016-10-20
00814584020879Phenom™ CatheterFG11150-1015-2XV01FG11150-1015-2X2016-10-20
00814584020916Phenom™ CatheterFG11170-0615-2XV01FG11170-0615-2X2016-10-20
00814584020923Phenom™ CatheterFG11170-1015-2XV01FG11170-1015-2X2016-10-20
00814584021357Phenom™ CatheterFG11150-1015-2RV01FG11150-1015-2R2016-10-20
00814584021395Phenom™ CatheterFG11170-0615-2RV01FG11170-0615-2R2016-10-20
00814584021401Phenom™ CatheterFG11170-1015-2RV01FG11170-1015-2R2016-10-20
00814584021821Phenom™ CatheterFG11150-0615-2JV01FG11150-0615-2J2016-10-20
00814584021838Phenom™ CatheterFG11150-1015-2JV01FG11150-1015-2J2016-10-20
00814584021876Phenom™ CatheterFG11170-0615-2JV01FG11170-0615-2J2016-10-20
00814584021883Phenom™ CatheterFG11170-1015-2JV01FG11170-1015-2J2016-10-20
00814584022309Phenom™ CatheterFG13150-0615-2SV01FG13150-0615-2S2016-10-20
00814584022316Phenom™ CatheterFG13150-1015-2SV01FG13150-1015-2S2016-10-20
00814584022354Phenom™ CatheterFG13170-0615-2SV01FG13170-0615-2S2016-10-20
00814584022781Phenom™ CatheterFG13150-0615-2XV01FG13150-0615-2X2016-10-20
00814584022798Phenom™ CatheterFG13150-1015-2XV01FG13150-1015-2X2016-10-20

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Primary DI, Brand, Company table
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00191506067380TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067397TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
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G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
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