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)
Top companies in KGZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2025 | B 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 |
KGZ | K760383 |
| Nov 26, 2025 | B 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 |
KGZ | K760383 |
| Nov 26, 2025 | B 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 |
KGZ | K760383 |
| May 7, 2025 | Galt 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 |
KGZ | None listed |
| Dec 14, 2020 | Galt 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 |
KGZ | None listed |
| May 2, 2019 | Cook Inc. Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT Terminated |
KGZ | None listed |
| May 4, 2018 | Vascular 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 |
KGZ | None listed |
| May 2, 2018 | Galt Medical Corporation TVS LPA, Catalog #: DIL-059-00 Terminated |
KGZ | K000737 K172487 |
| May 2, 2018 | Galt Medical Corporation Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, Terminated |
KGZ | None listed |
| May 2, 2018 | Galt 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 |
KGZ | None listed |
| Apr 11, 2018 | Arrow International Inc Extension Line Slide Clamps; Product codes: SA-09847 Terminated |
KGZ | None listed |
| Feb 1, 2017 | Cook Inc. Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Terminated |
KGZ | K132592 |
| Oct 20, 2016 | Micromedics, Inc. Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide Terminated |
KGZ | None listed |
| Aug 22, 2016 | Cook 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 |
KGZ | None listed |
| Aug 22, 2016 | Cook 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 |
KGZ | None listed |
| Oct 28, 2010 | LifeCell Corporation IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright. Terminated |
KGZ | None listed |
| Aug 25, 2010 | Arrow 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 |
KGZ | K781846 |
| May 5, 2010 | Arrow 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 |
KGZ | K781846 |
| Dec 14, 2009 | Merit 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 |
KGZ | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Percutaneous Sheath Introducers Terminated |
KGZ | K781846 |
| Mar 25, 2009 | Tri-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 |
KGZ | None listed |
| Jul 20, 2004 | Baxter 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 |
KGZ | K031676 |
| Jul 20, 2004 | Baxter 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 |
KGZ | K031676 |
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