Peregrine System™ Infusion Catheter

GUDID 00862468000349

Peregrine System™ Infusion Catheter (4-7 mm), 510k, US

ABLATIVE SOLUTIONS, INC.

Peripheral vascular intervention infusion catheter
Primary Device ID00862468000349
NIH Device Record Keyd44843a1-2aa8-4999-9cf3-bee2c0798cd4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeregrine System™ Infusion Catheter
Version Model NumberFG32111
Company DUNS078293273
Company NameABLATIVE SOLUTIONS, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com
Phone650 688-9743
Emailinfo@ablativesolutions.com

Device Dimensions

Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch
Length86 Centimeter
Device Size Text, specify0
Outer Diameter0.077 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100862468000349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

On-Brand Devices [Peregrine System™ Infusion Catheter ]

00862468000356Peregrine System™ Infusion Catheter (3-4 mm), 510k, US
00862468000349Peregrine System™ Infusion Catheter (4-7 mm), 510k, US

Trademark Results [Peregrine System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEREGRINE SYSTEM
PEREGRINE SYSTEM
85746944 5013150 Live/Registered
Ablative Solutions, Inc.
2012-10-05

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