FDA.reportPublic FDA data

Ultraverse® 035 PTA Dilatation Catheter

Primary DI
00801741091643
Brand
Ultraverse® 035 PTA Dilatation Catheter
Company
Bard Peripheral Vascular, Inc.
Model
U35100330
Catalog number
U35100330
Device description
Ultraverse 035 PTA Dilatation Catheter 3.0mm x 300mm balloon, 100cm shaft
Published
2015-12-04
Public version status
Update
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
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00801741091643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741091643008017410916438017410916430801741091643

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741234184EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
00801741234156EnCor EnCompass™ENCPSCENCPSC2026-02-04
00801741234163EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
00801741234095EnCor EnCompass™ENCP7GENCP7G2026-01-30
00801741234132EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
00801741234118EnCor EnCompass™ENCP12GENCP12G2026-01-28
00801741234149EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
00801741234170EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640119558639Passeo-18Biotronik AGLIT2016-08-24
07640119558646Passeo-18Biotronik AGLIT2016-08-24
07640119558653Passeo-18Biotronik AGLIT2016-08-24
07640119558660Passeo-18Biotronik AGLIT2016-08-24
07640119558677Passeo-18Biotronik AGLIT2016-08-24
07640119558684Passeo-18Biotronik AGLIT2016-08-24
07640119558691Passeo-18Biotronik AGLIT2016-08-24
07640119558707Passeo-18Biotronik AGLIT2016-08-24
07640119558714Passeo-18Biotronik AGLIT2016-08-24
07640119558721Passeo-18Biotronik AGLIT2016-08-24
07640119558738Passeo-18Biotronik AGLIT2016-08-24
07640119558745Passeo-18Biotronik AGLIT2016-08-24
07640119558752Passeo-18Biotronik AGLIT2016-08-24
07640119558769Passeo-18Biotronik AGLIT2016-08-24
07640119558776Passeo-18Biotronik AGLIT2016-08-24
07640119558783Passeo-18Biotronik AGLIT2016-08-24
07640119558790Passeo-18Biotronik AGLIT2016-08-24
07640119558806Passeo-18Biotronik AGLIT2016-08-24
07640119558813Passeo-18Biotronik AGLIT2016-08-24
07640119558820Passeo-18Biotronik AGLIT2016-08-24
07640119558837Passeo-18Biotronik AGLIT2016-08-24
07640119558844Passeo-18Biotronik AGLIT2016-08-24
07640119558851Passeo-18Biotronik AGLIT2016-08-24
07640119558868Passeo-18Biotronik AGLIT2016-08-24
07640119558875Passeo-18Biotronik AGLIT2016-08-24
07640119558882Passeo-18Biotronik AGLIT2016-08-24
07640119558899Passeo-18Biotronik AGLIT2016-08-24
07640119558905Passeo-18Biotronik AGLIT2016-08-24
07640119558912Passeo-18Biotronik AGLIT2016-08-24
07640119558929Passeo-18Biotronik AGLIT2016-08-24