Savvy Long PTA Dilatation Catheter 436-4015L

GUDID 00801741133169

Savvy Long PTA Dilatation Catheter 4.0mm x 150mm balloon, 120cm shaft

CLEARSTREAM TECHNOLOGIES LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID00801741133169
NIH Device Record Key234973bc-318c-4bc1-8ba7-d6bf01b5c1b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSavvy Long PTA Dilatation Catheter
Version Model Number436-4015L
Catalog Number436-4015L
Company DUNS989214291
Company NameCLEARSTREAM TECHNOLOGIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com
Phone+353()539237111
EmailENN-Complaints@crbard.com

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741133169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2016-09-16

On-Brand Devices [Savvy Long PTA Dilatation Catheter]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.