Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027150141

FEI Number

3027150141

Entity Name

SWIFTSURE INNOVATIONS INC.

City/State/Country

Pasadena Newfoundland and Labrador, CA

Establishment Address

36 Forest Rd, Pasadena Newfoundland and Labrador A0L 1K0, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Swiftsure Innovations Inc. (Owner Number: 10087742)

Owner / Operator Contact Address

36 Forest Rd, Pasadena, CA-NL A0L 1K0, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swiftsure SwishKit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

Matthew Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Swiftsure Innovations Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN
2126670	SCANLAN INTERNATIONAL, INC.	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027150141. Last updated year: 2026. Please use registration number 3027150141 when referencing this establishment in official correspondence.