FDA.reportPublic FDA data

Peregrine System™ Infusion Catheter

Primary DI
00862468000356
Brand
Peregrine System™ Infusion Catheter
Company
ABLATIVE SOLUTIONS, INC.
Model
FG32112
Device description
Peregrine System™ Infusion Catheter (3-4 mm), 510k, US
Published
2024-02-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231279000Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.2023-07-05KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862468000356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862468000356008624680003568624680003560862468000356

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length86Centimeter
Outer Diameter0.077Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650 688-9743info@ablativesolutions.com

Regulatory Flags#

DUNS number
078293273
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862468000349Peregrine System™ Infusion Catheter FG321112024-02-27
00862468000318Peregrine System Infusion CatheterFG321012017-05-24

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Primary DI, Brand, Company table
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00191506067403TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
00191506067410TruSelect™BOSTON SCIENTIFIC CORPORATIONKRA2026-06-01
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G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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15051684023955Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
00763000539351RebarMicro Therapeutics, Inc.KRA2022-02-27
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01