Hobbs Guiding Catheter

Primary DI: M84961300
Brand: Hobbs Guiding Catheter
Company: HOBBS MEDICAL, INC.
Model: 6130
Catalog number: 6130
Device description: The Guiding Catheter is a sterile device inserted through a compatible flexible endoscope to aid in the initial placement of a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is made of polytetrafluoroethylene (PTFE) with a radiopaque marker on the distal end. This is a single-use device.
Published: 2016-09-21
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Sterile: true
Single use: true

Contact Domains#

hobbsmedical.com

Product Codes#

Code, Name table
Code	Name
FGE	Catheter, Biliary, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K834351	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K834351	000	BILIARY INDWELLING STENT	Hobbs Medical, Inc.	1984-03-22	FGE

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
M84961300	Primary	HIBCC	0

GMDN Terms#

Term, Definition table
Term	Definition
Endoscopic stent-placement system	An assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). This is a single-use device.

Contacts#

Phone, Email table
Phone	Email
8606845875	customerservice@hobbsmedical.com

Regulatory Flags#

DUNS number: 076769355
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 DI	Brand	Model	Catalog	Published
M84921890	CleanCapture Aspiration Catheter	2189	2189	2026-01-14
M84921891	CleanCapture Aspiration Catheter	2189	2189	2026-01-14
M84960050	Hobbs Biliary Amsterdam Stent Kit	6005	6005	2016-09-21
M84960060	Hobbs Biliary Amsterdam Stent Kit	6006	6006	2016-09-21
M84960090	Hobbs Biliary Amsterdam Stent Kit	6009	6009	2016-09-21
M84960110	Hobbs Biliary Amsterdam Stent Kit	6011	6011	2016-09-21
M84960120	Hobbs Biliary Amsterdam Stent Kit	6012	6012	2016-09-21
M84960130	Hobbs Biliary Amsterdam Stent Kit	6013	6013	2016-09-21
M84960140	Hobbs Biliary Amsterdam Stent Kit	6014	6014	2016-09-21
M84960150	Hobbs Biliary Amsterdam Stent Kit	6015	6015	2016-09-21
M84963100	Freeman Pancreatic Flexi-Stent Kit	6310	6310	2016-09-21
M84963110	Freeman Pancreatic Flexi-Stent Kit	6311	6311	2016-09-21
M84963200	Freeman Pancreatic Flexi-Stent Kit	6320	6320	2016-09-21
M84963210	Freeman Pancreatic Flexi-Stent Kit	6321	6321	2016-09-21
M84965010	Freeman Pancreatic Flexi-Stent Kit	6501	6501	2016-09-21
M84965020	Freeman Pancreatic Flexi-Stent Kit	6502	6502	2016-09-21
M84965030	Freeman Pancreatic Flexi-Stent Kit	6503	6503	2016-09-21
M84965040	Freeman Pancreatic Flexi-Stent Kit	6504	6504	2016-09-21
M84965050	Freeman Pancreatic Flexi-Stent Kit	6505	6505	2016-09-21
M84965060	Freeman Pancreatic Flexi-Stent Kit	6506	6506	2016-09-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

Hobbs Guiding Catheter

Related Records#

Contact Domains#

Product Codes#

Product Code Classifications#

Premarket Submissions#

Premarket Details#

Identifiers And Packaging#

GMDN Terms#

Contacts#

Regulatory Flags#

Other Devices From This Company#

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