Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012102437

FEI Number

3012102437

Entity Name

Synergy Health AST, LLC

City/State/Country

Petaluma, CA, US

Establishment Address

3200 Lakeville Hwy, Suite 120, Petaluma, CA 94954, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Synergy Health AST, LLC (Owner Number: 10028672)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Spectranetics3268 (PT,SDB) - 518-033 QUICK-CROSS SUPPORT CATHETER, 18, 90CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-036 QUICK-CROSS SUPPORT CATHETER, 35, 90CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-037 QUICK-CROSS SUPPORT CATHETER, 35, 135CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-034 QUICK-CROSS SUPPORT CATHETER, 18, 135CM, 5 PACK Spectranetics3268 (PT,SDB) - 518-038 QUICK-CROSS SUPPORT CATHETER, 35, 150CM, 5 PACK PhillipsImage (PT,SDB) - 518-032 QUICK-CROSS SUPPORT CATHETER, 14, 135CM, 5 PACK PhillipsImage (PT,SDB) - 518-035 QUICK-CROSS SUPPORT CATHETER, 18, 150CM, 5 PACK Shockwave7578 (CR1,PT) - Shockwave M5+ Peripheral Intravascular Lithotripsy (IVL) Catheter Arlington8227 (SDB) - Curette, Nasal Shockwave7578 (PT, SDB) - Shockwave Peripheral Intravascular Lithotripsy (IVL) System LSO2556 (PT) - Osteo-P Bone Graph Substitue Shockwave7578 (PT,SDB) - Shockwave S4 Peripheral Intravascular Lithotripsy (IVL) Catheters Terumo2207 (PT) - Rika Plasma Bottle Shockwave7578 (PT,SDB*) - shockwave intravascular lithotripsy (ivl) system with the shockwave l6 peripheral ivl catheter PhillipsImage (PT,SDB) - 60090-01 QUICKCAT EXTRACTION CATHETER Arthocare8208 (CR1) - CAP-FIXCAP-FIX SUTURE PASSER 70 DEG Arthocare8208 (CR1) - CAP-FIX SUTURE PASSER 45 DEG Arthocare8208 (CR2) - ACCU-PASS DIRECT Suture Passer, Crescent XL Toby7429 (PT) - PASSER, RETRACTOR Shockwave7578 (PT,SDB*) - Shockwave C2 Coronary IVL Catheters Shockwave7578 (PT,SDB*) - Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter Shockwave7578 (CR1) - Intravascular Lithotripsy (IVL) System with the Shockwave C2 Aero Coronary IVL Catheter Xvivo7433 (PT) - STEEN Solution Xvivo7433 (PT) - XVIVO Disposable Lung Circuit Xvivo7433 (PT) - XVIVO Disposable Kit Xvivo7433 (PT) - XVIVO Lung Cannula Set Xvivo7433 (PT) - XVIVO Organ Chamber Xvivo7433 (PT) - XPS Xvivo7433 (PT) - XVIVO PGM Surmodics4211 (PT,SDB) - SurVeil Drug-Coated Balloon Shockwave7578 (PT,SDB) - Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) Catheter Shockwave7578 (PT, SDB) - Lithoplasty Peripheral Balloon Dilatation Catheter Mortan11220 (PT) - Device, Irrigation, Ocular Surgery StimLab7532 (PT) - Allacor P StimLab7532 (PT) - Corplex P Intersect7571 (PT,SDB) - Drug-eluting sinus stent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-06-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-08-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-11-13
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2021-12-22
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2025-01-09
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2017-07-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-11-13
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-02-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-09-23
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2019-06-13
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2019-06-13
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-06-13
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-08-22
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2024-10-30
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2024-09-19
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2012-11-13
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-11-16
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2020-11-13
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-11-20
HWQ	Passer	Orthopedic	Class 1	888.4540	2012-11-15
QMG	Shockwave Intravascular Lithotripsy System	Unknown	Class 3	N/A	2021-02-25
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-06-13
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2019-06-13
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	General, Plastic Surgery	Class 2	878.3300	2019-06-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-01-21
PHO	Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	Unknown	Class 3	N/A	2019-12-31
NQR	Sealant, Dural	Unknown	Class 3	N/A	2023-08-17
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2023-11-30
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2020-02-06
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2023-08-16
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2024-09-19
PQF	Sensor, Glucose, Invasive, Non-Adjunctive	Unknown	Class 3	N/A	2024-09-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-06-03
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2019-06-03
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2017-07-20
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2023-09-29
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-11-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-01-21
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-01-21
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2012-11-13
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	Unknown	Class 3	N/A	2024-08-07
NQR	Sealant, Dural	Unknown	Class 3	N/A	2023-08-17
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-06-28
OWO	Drug-Eluting Sinus Stent	Unknown	Class 3	N/A	2012-11-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2019-06-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Synergy Health AST, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010421104	STERIS TOMOE SINGAPORE PTE LTD	Singapore South West, SG
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US
3007738736	Synergy Health AST, SRL	Alajuela, CR
3017636737	STERIS Corporation de Republica Dominicana, S.R.L.	Santo Domingo, DO
2030598	Synergy Health AST, LLC	SAN DIEGO, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012102437. Last updated year: 2026. Please use registration number 3012102437 when referencing this establishment in official correspondence.