Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009905888

FEI Number

3009905888

Entity Name

BLUE LINE STERILIZATION SERVICES

City/State/Country

Novato, CA, US

Establishment Address

401-C Bel Marin Keys Blvd., Novato, CA 94949, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Blue Line Sterilization Services LLC (Owner Number: 10042280)

Owner / Operator Contact Address

401-C Bel Marin Keys Blvd., Novato, CA 94949, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

The Fugo Blade For Glaucoma Fugo Blade For Peripheral Iridotomy, mod Multiflex Steerable Sheath CenterCross Catheter The Fugo Blade For Dentistry Nerve Tape SIRA RFA Electrosurgical Device Aveli Medusa Vascular Plug VERUS MicroCross Catheter MicroCross Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NCR	Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered	Ophthalmic	Class 2	886.4100	2014-03-05
NCR	Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered	Ophthalmic	Class 2	886.4100	2014-03-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-04-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-07-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-12-12
EKZ	Unit, Electrosurgical, And Accessories, Dental	Dental	Class 2	872.4920	2014-03-05
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2026-06-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-05-15
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-09-13
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2023-09-13
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	General, Plastic Surgery	Class 2	878.4790	2023-09-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-03-05
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-02-01
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-05-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-07-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-07-05

Official Correspondent

Brant Gard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blue Line Sterilization Services LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Similar Registrations

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3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009905888. Last updated year: 2026. Please use registration number 3009905888 when referencing this establishment in official correspondence.