Phoenix Wire Support Clip

GUDID 00845225002671

VOLCANO ATHEROMED, INC.

Mechanical atherectomy system catheter, peripheral
Primary Device ID00845225002671
NIH Device Record Key68aca41b-94dc-4b3d-9084-6a1709dcaeb9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoenix Wire Support Clip
Version Model NumberP01818
Company DUNS788341084
Company NameVOLCANO ATHEROMED, INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225002671 [Primary]

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-17
Device Publish Date2016-09-01

Devices Manufactured by VOLCANO ATHEROMED, INC.

00845225003463 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 1.5mm x 149cm, 4F
00845225003470 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 1.8mm x 130cm, 5F
00845225003487 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 1.8mm x 149cm, 5F
00845225003494 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 2.2mm x 130cm, 6F
00845225003500 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Catheter, 2.2mm x 149cm, 6F
00845225003517 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Deflecting Catheter, 2.2mm x 130cm, 6F
00845225003524 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy Deflecting Catheter, 2.4mm x 130cm, 7F
00845225003531 - Phoenix Atherectomy2024-07-16 Phoenix Atherectomy System, 1.5mm x 149cm, 4F

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