Sleek PTA Dilatation Catheter 425-2518X

GUDID 00801741132391

Sleek PTA Dilatation Catheter 2.5mm x 180mm balloon, 155cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00801741132391
• NIH Device Record Key: 3398f277-3924-4756-8842-d23f62e70116
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleek PTA Dilatation Catheter
• Version Model Number: 425-2518X
• Catalog Number: 425-2518X
• 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
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com
• Phone: +353()539237111
• Email: ENN-Complaints@crbard.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741132391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072947

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 PTA Dilatation Catheter]

• 00801741132643: Sleek PTA Dilatation Catheter 4.0mm x 220mm balloon, 155cm shaft
• 00801741132636: Sleek PTA Dilatation Catheter 4.0mm x 180mm balloon, 155cm shaft
• 00801741132629: Sleek PTA Dilatation Catheter 4.0mm x 150mm balloon, 155cm shaft
• 00801741132612: Sleek PTA Dilatation Catheter 4.0mm x 120mm balloon, 150cm shaft
• 00801741132605: Sleek PTA Dilatation Catheter 4.0mm x 100mm balloon, 150cm shaft
• 00801741132599: Sleek PTA Dilatation Catheter 4.0mm x 80mm balloon, 150cm shaft
• 00801741132582: Sleek PTA Dilatation Catheter 4.0mm x 60mm balloon, 150cm shaft
• 00801741132575: Sleek PTA Dilatation Catheter 4.0mm x 40mm balloon, 150cm shaft
• 00801741132568: Sleek PTA Dilatation Catheter 3.5mm x 220mm balloon, 155cm shaft
• 00801741132551: Sleek PTA Dilatation Catheter 3.5mm x 180mm balloon, 155cm shaft
• 00801741132544: Sleek PTA Dilatation Catheter 3.5mm x 150mm balloon, 155cm shaft
• 00801741132537: Sleek PTA Dilatation Catheter 3.5mm x 120mm balloon, 150cm shaft
• 00801741132520: Sleek PTA Dilatation Catheter 3.5mm x 100mm balloon, 150cm shaft
• 00801741132513: Sleek PTA Dilatation Catheter 3.5mm x 80mm balloon, 150cm shaft
• 00801741132506: Sleek PTA Dilatation Catheter 3.5mm x 60mm balloon, 150cm shaft
• 00801741132490: Sleek PTA Dilatation Catheter 3.5mm x 40mm balloon, 150cm shaft
• 00801741132483: Sleek PTA Dilatation Catheter 3.0mm x 220mm balloon, 155cm shaft
• 00801741132476: Sleek PTA Dilatation Catheter 3.0mm x 180mm balloon, 155cm shaft
• 00801741132469: Sleek PTA Dilatation Catheter 3.0mm x 150mm balloon, 155cm shaft
• 00801741132452: Sleek PTA Dilatation Catheter 3.0mm x 120mm balloon, 150cm shaft
• 00801741132445: Sleek PTA Dilatation Catheter 3.0mm x 100mm balloon, 150cm shaft
• 00801741132438: Sleek PTA Dilatation Catheter 3.0mm x 80mm balloon, 150cm shaft
• 00801741132421: Sleek PTA Dilatation Catheter 3.0mm x 60mm balloon, 150cm shaft
• 00801741132414: Sleek PTA Dilatation Catheter 3.0mm x 40mm balloon, 150cm shaft
• 00801741132407: Sleek PTA Dilatation Catheter 2.5mm x 220mm balloon, 155cm shaft
• 00801741132391: Sleek PTA Dilatation Catheter 2.5mm x 180mm balloon, 155cm shaft
• 00801741132384: Sleek PTA Dilatation Catheter 2.5mm x 150mm balloon, 155cm shaft
• 00801741132377: Sleek PTA Dilatation Catheter 2.5mm x 120mm balloon, 150cm shaft
• 00801741132360: Sleek PTA Dilatation Catheter 2.5mm x 100mm balloon, 150cm shaft
• 00801741132322: Sleek PTA Dilatation Catheter 2.5mm x 80mm balloon, 150cm shaft
• 00801741132315: Sleek PTA Dilatation Catheter 2.5mm x 60mm balloon, 150cm shaft
• 00801741132308: Sleek PTA Dilatation Catheter 2.5mm x 40mm balloon, 150cm shaft
• 00801741132292: Sleek PTA Dilatation Catheter 2.0mm x 220mm balloon, 155cm shaft
• 00801741132285: Sleek PTA Dilatation Catheter 2.0mm x 180mm balloon, 155cm shaft
• 00801741132278: Sleek PTA Dilatation Catheter 2.0mm x 150mm balloon, 155cm shaft
• 00801741132261: Sleek PTA Dilatation Catheter 2.0mm x 120mm balloon, 150cm shaft
• 00801741132254: Sleek PTA Dilatation Catheter 2.0mm x 100mm balloon, 150cm shaft
• 00801741132247: Sleek PTA Dilatation Catheter 2.0mm x 80mm balloon, 150cm shaft
• 00801741132230: Sleek PTA Dilatation Catheter 2.0mm x 60mm balloon, 150cm shaft
• 00801741132223: Sleek PTA Dilatation Catheter 2.0mm x 40mm balloon, 150cm shaft