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Panels › General, Plastic Surgery › Product code KGZ · Class 1

Accessories, Catheter

Regulation 878.4200

0510(k)s in 12 months (29 all time)
3recalls in 12 months (23 all time)
10recalls that name a 510(k)
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Top companies in KGZ

DateFirm and productCodeLinked 510(k)
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
KGZK760383
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
KGZK760383
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
KGZK760383
May 7, 2025Galt Medical Corporation
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Open, Classified
KGZNone listed
Dec 14, 2020Galt Medical Corporation
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Terminated
KGZNone listed
May 2, 2019Cook Inc.
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Terminated
KGZNone listed
May 4, 2018Vascular Solutions, Inc.
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and sm
Terminated
KGZNone listed
May 2, 2018Galt Medical Corporation
TVS LPA, Catalog #: DIL-059-00
Terminated
KGZK000737
K172487
May 2, 2018Galt Medical Corporation
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Terminated
KGZNone listed
May 2, 2018Galt Medical Corporation
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05
Terminated
KGZNone listed
Apr 11, 2018Arrow International Inc
Extension Line Slide Clamps; Product codes: SA-09847
Terminated
KGZNone listed
Feb 1, 2017Cook Inc.
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Terminated
KGZK132592
Oct 20, 2016Micromedics, Inc.
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Terminated
KGZNone listed
Aug 22, 2016Cook Inc.
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interv
Terminated
KGZNone listed
Aug 22, 2016Cook Inc.
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interven
Terminated
KGZNone listed
Oct 28, 2010LifeCell Corporation
IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.
Terminated
KGZNone listed
Aug 25, 2010Arrow International Inc
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
Terminated
KGZK781846
May 5, 2010Arrow International Inc
Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 Permits venous
Terminated
KGZK781846
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of
Terminated
KGZNone listed
Jun 24, 2009Arrow International Inc
Arrow Percutaneous Sheath Introducers
Terminated
KGZK781846
Mar 25, 2009Tri-State Hospital Supply Corporation
Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray, Tri-State Supply Corporation, Howell, MI.; reorder UVT 170.
Terminated
KGZNone listed
Jul 20, 2004Baxter Healthcare Corp.
Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30 units per case
Terminated
KGZK031676
Jul 20, 2004Baxter Healthcare Corp.
Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); Baxter Healthcare Corporation, Deerfield, IL 60015 USA; 30
Terminated
KGZK031676

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