Sleek OTW PTA Dilatation Catheter 426-4028X

GUDID 00801741133954

Sleek OTW PTA Dilatation Catheter 4.0mm x 280mm balloon, 150cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00801741133954
• NIH Device Record Key: 1b6c255e-a0f4-4b0c-b7c5-12c40d76cdb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleek OTW PTA Dilatation Catheter
• Version Model Number: 426-4028X
• Catalog Number: 426-4028X
• Company DUNS: 989214291
• Company Name: CLEARSTREAM TECHNOLOGIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741133954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130786

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2016-09-16

On-Brand Devices [Sleek OTW PTA Dilatation Catheter]

• 00801741134036: Sleek OTW PTA Dilatation Catheter 5.0mm x 280mm balloon, 150cm shaft
• 00801741134029: Sleek OTW PTA Dilatation Catheter 5.0mm x 220mm balloon, 150cm shaft
• 00801741134012: Sleek OTW PTA Dilatation Catheter 5.0mm x 150mm balloon, 150cm shaft
• 00801741134005: Sleek OTW PTA Dilatation Catheter 5.0mm x 120mm balloon, 150cm shaft
• 00801741133992: Sleek OTW PTA Dilatation Catheter 5.0mm x 100mm balloon, 150cm shaft
• 00801741133985: Sleek OTW PTA Dilatation Catheter 5.0mm x 80mm balloon, 150cm shaft
• 00801741133978: Sleek OTW PTA Dilatation Catheter 5.0mm x 40mm balloon, 150cm shaft
• 00801741133961: Sleek OTW PTA Dilatation Catheter 5.0mm x 20mm balloon, 150cm shaft
• 00801741133954: Sleek OTW PTA Dilatation Catheter 4.0mm x 280mm balloon, 150cm shaft
• 00801741133947: Sleek OTW PTA Dilatation Catheter 4.0mm x 220mm balloon, 150cm shaft
• 00801741133930: Sleek OTW PTA Dilatation Catheter 4.0mm x 150mm balloon, 150cm shaft
• 00801741133923: Sleek OTW PTA Dilatation Catheter 4.0mm x 120mm balloon, 150cm shaft
• 00801741133916: Sleek OTW PTA Dilatation Catheter 4.0mm x 100mm balloon, 150cm shaft
• 00801741133909: Sleek OTW PTA Dilatation Catheter 4.0mm x 80mm balloon, 150cm shaft
• 00801741133893: Sleek OTW PTA Dilatation Catheter 4.0mm x 40mm balloon, 150cm shaft
• 00801741133886: Sleek OTW PTA Dilatation Catheter 4.0mm x 20mm balloon, 150cm shaft
• 00801741133879: Sleek OTW PTA Dilatation Catheter 3.5mm x 280mm balloon, 150cm shaft
• 00801741133862: Sleek OTW PTA Dilatation Catheter 3.5mm x 220mm balloon, 150cm shaft
• 00801741133855: Sleek OTW PTA Dilatation Catheter 3.5mm x 150mm balloon, 150cm shaft
• 00801741133848: Sleek OTW PTA Dilatation Catheter 3.5mm x 120mm balloon, 150cm shaft
• 00801741133831: Sleek OTW PTA Dilatation Catheter 3.5mm x 100mm balloon, 150cm shaft
• 00801741133824: Sleek OTW PTA Dilatation Catheter 3.5mm x 80mm balloon, 150cm shaft
• 00801741133817: Sleek OTW PTA Dilatation Catheter 3.5mm x 40mm balloon, 150cm shaft
• 00801741133800: Sleek OTW PTA Dilatation Catheter 3.5mm x 20mm balloon, 150cm shaft
• 00801741133794: Sleek OTW PTA Dilatation Catheter 3.0mm x 280mm balloon, 150cm shaft
• 00801741133787: Sleek OTW PTA Dilatation Catheter 3.0mm x 220mm balloon, 150cm shaft
• 00801741133770: Sleek OTW PTA Dilatation Catheter 3.0mm x 150mm balloon, 150cm shaft
• 00801741133763: Sleek OTW PTA Dilatation Catheter 3.0mm x 120mm balloon, 150cm shaft
• 00801741133756: Sleek OTW PTA Dilatation Catheter 3.0mm x 100mm balloon, 150cm shaft
• 00801741133749: Sleek OTW PTA Dilatation Catheter 3.0mm x 80mm balloon, 150cm shaft
• 00801741133732: Sleek OTW PTA Dilatation Catheter 3.0mm x 40mm balloon, 150cm shaft
• 00801741133725: Sleek OTW PTA Dilatation Catheter 3.0mm x 20mm balloon, 150cm shaft
• 00801741133718: Sleek OTW PTA Dilatation Catheter 2.5mm x 280mm balloon, 150cm shaft
• 00801741133701: Sleek OTW PTA Dilatation Catheter 2.5mm x 220mm balloon, 150cm shaft
• 00801741133695: Sleek OTW PTA Dilatation Catheter 2.5mm x 150mm balloon, 150cm shaft
• 00801741133688: Sleek OTW PTA Dilatation Catheter 2.5mm x 120mm balloon, 150cm shaft
• 00801741133671: Sleek OTW PTA Dilatation Catheter 2.5mm x 100mm balloon, 150cm shaft
• 00801741133664: Sleek OTW PTA Dilatation Catheter 2.5mm x 80mm balloon, 150cm shaft
• 00801741133657: Sleek OTW PTA Dilatation Catheter 2.5mm x 40mm balloon, 150cm shaft
• 00801741133640: Sleek OTW PTA Dilatation Catheter 2.5mm x 20mm balloon, 150cm shaft
• 00801741133633: Sleek OTW PTA Dilatation Catheter 2.0mm x 280mm balloon, 150cm shaft
• 00801741133626: Sleek OTW PTA Dilatation Catheter 2.0mm x 220mm balloon, 150cm shaft
• 00801741133619: Sleek OTW PTA Dilatation Catheter 2.0mm x 150mm balloon, 150cm shaft
• 00801741133602: Sleek OTW PTA Dilatation Catheter 2.0mm x 120mm balloon, 150cm shaft
• 00801741133596: Sleek OTW PTA Dilatation Catheter 2.0mm x 100mm balloon, 150cm shaft
• 00801741133589: Sleek OTW PTA Dilatation Catheter 2.0mm x 80mm balloon, 150cm shaft
• 00801741133572: Sleek OTW PTA Dilatation Catheter 2.0mm x 40mm balloon, 150cm shaft
• 00801741133565: Sleek OTW PTA Dilatation Catheter 2.0mm x 20mm balloon, 150cm shaft
• 00801741133558: Sleek OTW PTA Dilatation Catheter 1.5mm x 120mm balloon, 150cm shaft
• 00801741133541: Sleek OTW PTA Dilatation Catheter 1.5mm x 100mm balloon, 150cm shaft