Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007830707

FEI Number

3007830707

Entity Name

ADVANCED LIFESCIENCES PVT. LTD.

City/State/Country

New Delhi, IN

Establishment Address

D-22 Okhla Industrial Area Phase-1, New Delhi 110020, IN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Advanced LifeSciences Pvt. Ltd. (Owner Number: 10058669)

Owner / Operator Contact Address

D-22 Okhla Industrial Phase-1, New Delhi, IN-DL 110020, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NUCATH AD-Valve Glider ALSPL GUIDEWIRE Radial Artery Compression Device Introducer Needle Introducer Sheath Hemostasis Valve Manifold & 3 Way Stopcock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-01-10
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2018-10-18
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2023-01-30
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2024-05-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-05-10
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2024-05-10

Official Correspondent

Shubhankar Aggarwal

US Agent Details

PASQUALE CARVELLI Business: Cosmereg LLC Email: pasquale.carvelli@cosmereg.com Phone: (727) 3509380

Related Public Records

Same Entity

Advanced LifeSciences Pvt. Ltd.

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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

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.

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007830707. Last updated year: 2026. Please use registration number 3007830707 when referencing this establishment in official correspondence.