Savvy Long PTA Dilatation Catheter 436-6015X

GUDID 00801741133428

Savvy Long PTA Dilatation Catheter 6.0mm x 150mm balloon, 150cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 00801741133428
• NIH Device Record Key: 18a73a89-d79f-4b6f-a6e1-e5e8f0316d4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Savvy Long PTA Dilatation Catheter
• Version Model Number: 436-6015X
• Catalog Number: 436-6015X
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741133428 [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 [Savvy Long PTA Dilatation Catheter]

• 00801741133480: Savvy Long PTA Dilatation Catheter 6.0mm x 220mm balloon, 150cm shaft
• 00801741133473: Savvy Long PTA Dilatation Catheter 6.0mm x 220mm balloon, 80cm shaft
• 00801741133466: Savvy Long PTA Dilatation Catheter 6.0mm x 220mm balloon, 120cm shaft
• 00801741133459: Savvy Long PTA Dilatation Catheter 6.0mm x 180mm balloon, 150cm shaft
• 00801741133442: Savvy Long PTA Dilatation Catheter 6.0mm x 180mm balloon, 80cm shaft
• 00801741133435: Savvy Long PTA Dilatation Catheter 6.0mm x 180mm balloon, 120cm shaft
• 00801741133428: Savvy Long PTA Dilatation Catheter 6.0mm x 150mm balloon, 150cm shaft
• 00801741133411: Savvy Long PTA Dilatation Catheter 6.0mm x 150mm balloon, 80cm shaft
• 00801741133404: Savvy Long PTA Dilatation Catheter 6.0mm x 150mm balloon, 120cm shaft
• 00801741133398: Savvy Long PTA Dilatation Catheter 6.0mm x 120mm balloon, 150cm shaft
• 00801741133381: Savvy Long PTA Dilatation Catheter 6.0mm x 120mm balloon, 80cm shaft
• 00801741133374: Savvy Long PTA Dilatation Catheter 6.0mm x 120mm balloon, 120cm shaft
• 00801741133367: Savvy Long PTA Dilatation Catheter 5.0mm x 220mm balloon, 150cm shaft
• 00801741133350: Savvy Long PTA Dilatation Catheter 5.0mm x 220mm balloon, 80cm shaft
• 00801741133343: Savvy Long PTA Dilatation Catheter 5.0mm x 220mm balloon, 120cm shaft
• 00801741133336: Savvy Long PTA Dilatation Catheter 5.0mm x 180mm balloon, 150cm shaft
• 00801741133329: Savvy Long PTA Dilatation Catheter 5.0mm x 180mm balloon, 80cm shaft
• 00801741133312: Savvy Long PTA Dilatation Catheter 5.0mm x 180mm balloon, 120cm shaft
• 00801741133305: Savvy Long PTA Dilatation Catheter 5.0mm x 150mm balloon, 150cm shaft
• 00801741133299: Savvy Long PTA Dilatation Catheter 5.0mm x 150mm balloon, 80cm shaft
• 00801741133282: Savvy Long PTA Dilatation Catheter 5.0mm x 150mm balloon, 120cm shaft
• 00801741133275: Savvy Long PTA Dilatation Catheter 5.0mm x 120mm balloon, 150cm shaft
• 00801741133268: Savvy Long PTA Dilatation Catheter 5.0mm x 120mm balloon, 80cm shaft
• 00801741133251: Savvy Long PTA Dilatation Catheter 5.0mm x 120mm balloon, 120cm shaft
• 00801741133244: Savvy Long PTA Dilatation Catheter 4.0mm x 220mm balloon, 150cm shaft
• 00801741133237: Savvy Long PTA Dilatation Catheter 4.0mm x 220mm balloon, 80cm shaft
• 00801741133220: Savvy Long PTA Dilatation Catheter 4.0mm x 220mm balloon, 120cm shaft
• 00801741133213: Savvy Long PTA Dilatation Catheter 4.0mm x 180mm balloon, 150cm shaft
• 00801741133206: Savvy Long PTA Dilatation Catheter 4.0mm x 180mm balloon, 80cm shaft
• 00801741133190: Savvy Long PTA Dilatation Catheter 4.0mm x 180mm balloon, 120cm shaft
• 00801741133183: Savvy Long PTA Dilatation Catheter 4.0mm x 150mm balloon, 150cm shaft
• 00801741133176: Savvy Long PTA Dilatation Catheter 4.0mm x 150mm balloon, 80cm shaft
• 00801741133169: Savvy Long PTA Dilatation Catheter 4.0mm x 150mm balloon, 120cm shaft
• 00801741133152: Savvy Long PTA Dilatation Catheter 4.0mm x 120mm balloon, 150cm shaft
• 00801741133145: Savvy Long PTA Dilatation Catheter 4.0mm x 120mm balloon, 80cm shaft
• 00801741133138: Savvy Long PTA Dilatation Catheter 4.0mm x 120mm balloon, 120cm shaft
• 00801741133121: Savvy Long PTA Dilatation Catheter 3.5mm x 220mm balloon, 150cm shaft
• 00801741133114: Savvy Long PTA Dilatation Catheter 3.5mm x 220mm balloon, 80cm shaft
• 00801741133107: Savvy Long PTA Dilatation Catheter 3.5mm x 220mm balloon, 120cm shaft
• 00801741133091: Savvy Long PTA Dilatation Catheter 3.5mm x 180mm balloon, 150cm shaft
• 00801741133084: Savvy Long PTA Dilatation Catheter 3.5mm x 180mm balloon, 80cm shaft
• 00801741133077: Savvy Long PTA Dilatation Catheter 3.5mm x 180mm balloon, 120cm shaft
• 00801741133060: Savvy Long PTA Dilatation Catheter 3.5mm x 150mm balloon, 150cm shaft
• 00801741133053: Savvy Long PTA Dilatation Catheter 3.5mm x 150mm balloon, 80cm shaft
• 00801741133046: Savvy Long PTA Dilatation Catheter 3.5mm x 150mm balloon, 120cm shaft
• 00801741133039: Savvy Long PTA Dilatation Catheter 3.5mm x 120mm balloon, 150cm shaft
• 00801741133022: Savvy Long PTA Dilatation Catheter 3.5mm x 120mm balloon, 80cm shaft
• 00801741133015: Savvy Long PTA Dilatation Catheter 3.5mm x 120mm balloon, 120cm shaft
• 00801741133008: Savvy Long PTA Dilatation Catheter 3.0mm x 220mm balloon, 150cm shaft
• 00801741132995: Savvy Long PTA Dilatation Catheter 3.0mm x 220mm balloon, 80cm shaft