What is FDA product code OFL?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Split Sheath Introducer Kit · Percutaneous Sheath Introducer Kit → Cardiovascular

Name: Split Sheath Introducer Kit
Brand: Split Sheath Introducer Kit

2manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Shanghai (1).

Chinese manufacturers registered for FDA product code OFL
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71
Shanghai INT Medical Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	10

Record

Regulatory record for Split Sheath Introducer Kit
Listed by	Argon Medical Devices, Inc., United States
FDA product code	OFL
Device type	Percutaneous Sheath Introducer Kit
Device class	Class 2
Regulation	21 CFR 870.1340
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2016-09-20
Record revised	2026-05-11 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 10
Distribution end date	2024-01-30

Catalogue Numbers

Catalogue numbers for Split Sheath Introducer Kit
Catalogue number	Size	Status
491114A	9F	Withdrawn
491115A	10F	Withdrawn
491110A	11F	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Micro-Introducer Kit	Galt Medical Corp.	53
Micro-Access Tearaway Introducer Kit	Galt Medical Corp.	49
Tearaway Introducer Kit	Galt Medical Corp.	35
Stiffen Micro-Introducer Kit	Galt Medical Corp.	28
Elite Transitionless Micro-Introducer Kit	Galt Medical Corp.	24
Valved Tearaway Kit	Galt Medical Corp.	24
Typenex Introducer Set	Typenex Medical, LLC	23
Transitionless Micro-Introducer Kit	Galt Medical Corp.	20
Transitionless Stiffen Micro-Introducer Kit	Galt Medical Corp.	19
Seamless™	B. Braun Medical Inc.	19
Stradis	Stradis Healthcare	16
TVS LPA	Galt Medical Corp.	13

Showing 12 of 40. All products under Percutaneous Sheath Introducer Kit

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Split Sheath Introducer Kit

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies