FDA.report

Atlas® Gold

Primary DI
00801741060946
Brand
Atlas® Gold
Company
Bard Peripheral Vascular, Inc.
Model
ATG120204
Catalog number
ATG120204
Device description
Atlas® Gold PTA Dilatation Catheter 20 mm x 40 mm, 120 cm catheter
Published
2016-08-24
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

Related Records

Contact Domains

Product Codes

CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741060946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741060946008017410609468017410609460801741060946

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags

DUNS number
135057938
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
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
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28
10801741234146EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
10801741234177EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741226332UltraCor™ Twirl™UCLS17UCLS172025-04-01
10801741226349UltraCor™ Twirl™UCVR17UCVR172025-04-01
10801741230605PeritX90-201090-20102025-01-23
10801741230612PeritX90-200590-20052025-01-23
10801741230636PeritX90-202090-20202025-01-23
50885403464032JamshidiEJC3513EJC35132017-10-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
30841156103983SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156103993SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104006SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104013SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104020SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104037SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20841156104044SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
30841156104058SUPERCROSSTELEFLEX INCORPORATEDDQY2026-03-23
20801902195429ARROWTELEFLEX INCORPORATEDDQY2026-03-17
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
20801902225256ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225263ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225270ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20801902225287ARROWTELEFLEX INCORPORATEDDQY2026-02-19
20841156103887TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
20841156103894TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
30841156103914TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
20841156103931TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
30841156103952TURNPIKETELEFLEX INCORPORATEDDQY2026-02-19
00763000747459NAMEDTRONIC, INC.DQY2026-02-09
00763000747466NAMEDTRONIC, INC.DQY2026-02-09
00763000747473NAMEDTRONIC, INC.DQY2026-02-09
00763000747480NAMEDTRONIC, INC.DQY2026-02-09
04547327165563ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165570ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165587ASAHI VelouteASAHI INTECC CO., LTD.DQY2026-02-05
04547327165594ASAHI Veloute C3ASAHI INTECC CO., LTD.DQY2026-02-05