Who else makes this device?

Name: Procedure Products Syringes
Brand: Procedure Products Syringes

Procedure Products Syringes · Dilator, Vessel, for Percutaneous Catheterization → Cardiovascular

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code DRE
Manufacturer	City	Province	Registered as	Device types
Lifetech Scientific (Shenzhen) Co,.ltd	Shenzhen	Guangdong	Manufacturer	3

Record

Regulatory record for Procedure Products Syringes
Listed by	Procedure Products, Inc., United States
FDA product code	DRE
Device type	Dilator, Vessel, For Percutaneous Catheterization
Device class	Class 2
Regulation	21 CFR 870.1310
Establishment	Manufacturer
510(k)	K810859
Record published	2017-02-07
Record revised	2024-06-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Procedure Products Syringes
Catalogue number	Size	Status
31-1835		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prelude®	Merit Medical Systems, Inc.	323
Prelude PRO™	Merit Medical Systems, Inc.	132
Cook	Cook Incorporated	125
Avanti	Cordis Corp.	81
Dilator, Vessel, For Percutaneous Catheterization	B. Braun Interventional Systems, Inc.	59
Merit MAK™	Merit Medical Systems, Inc.	49
Prelude ACT™	Merit Medical Systems, Inc.	38
AngioDynamics	Navilyst Medical, Inc.	38
Super Sheath	Togo Medikit Co., Ltd.	31
Avanti	Cordis US Corp.	29
Mini Stick MAX	AngioDynamics, Inc.	28
OneStic Micro-Access Introducer	Argon Medical Devices, Inc.	27

Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K810859	1981-04-11

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Procedure Products Syringes
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Procedure Products, Inc.	510(k) number	2015-10-27	Class II	Nonconforming Material/Component	The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle	1100 pieces	2016-04-01

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.

Procedure Products Syringes