Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008514120

FEI Number

3008514120

Entity Name

PDV MedTech

City/State/Country

Morgan Hill, CA, US

Establishment Address

18655 Madrone Pkwy, Morgan Hill, CA 95037, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PDV MedTech (Owner Number: 10033287)

Owner / Operator Contact Address

18655 Madrone Parkway, Morgan Hill, CA 95037, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ConfidaTM Expandable Sheath OnPharma Onset Cartridge Connector OsteoRepair Onset EZ Device InterSep Craniosculpt OnPharma Onset Mixing Pen VAN Hip Fracture System Prodigy Thrombectomy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-11-14
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-07-29
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-05-04
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2025-09-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-12-11
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2020-06-11
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2010-07-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-06-12
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-12-06

Official Correspondent

Andrew Figueroa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PDV MedTech

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-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

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3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
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 3008514120. Last updated year: 2026. Please use registration number 3008514120 when referencing this establishment in official correspondence.