Panels › General Hospital › Product code FOZ · Class 2

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Regulation 880.5200

8510(k)s in 12 months (508 all time)

6recalls in 12 months (394 all time)

359recalls that name a 510(k)

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Top companies in FOZ

Company	510(k)s	Recalls
Arrow International, Inc.	1	155
Cook Incorporated	13	123
Becton Dickinson Infusion Therapy Systems, Inc.	30	15
Menlo Care, Inc.	22	0
Am2 Pat, Inc.	1	15
B.Braun Medical, Inc.	12	2
Delta Med Spa	3	11
Parke-Davis Co.	14	0
Becton Dickinson Medical Systems	0	12
Becton Dickinson Vascular Access, Inc.	11	0

Decided	510(k)	Device and applicant	Code
Jun 20, 2001	K010406	JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G Jms Co., Ltd., JP	FOZ
May 21, 2001	K003187	VACUCATH I.V. CATHETER INTRODUCTER Auto/Cath Vascular Access, Inc.	FOZ
Mar 21, 2001	K003553	0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic	FOZ
Feb 23, 2001	K010021	MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S Medical Components, Inc.	FOZ
Jan 24, 2001	K010034	DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- Cook, Inc.	FOZ
Dec 4, 2000	K003245	HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML Baxter Healthcare Corp	FOZ
Nov 17, 2000	K002786	BIOSENSORS CENTRAL VENOUS CATHETER KITS Sunscope Intl., Inc.	FOZ
Oct 19, 2000	K001795	THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD Avitro, LLC	FOZ
Oct 19, 2000	K000632	0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE Avitro, LLC	FOZ
Sep 7, 2000	K000997	ZORTRAN DETECTOR Lucent Medical Systems	FOZ
Jul 27, 2000	K001616	MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE Abbott Laboratories	FOZ
Jul 26, 2000	K002033	BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS Becton Dickinson Infusion Therapy Systems, Inc.	FOZ
Jun 13, 2000	K992532	VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING Baxter Healthcare Corp	FOZ
Jun 12, 2000	K993518	MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL Medefil, Inc.	FOZ
May 2, 2000	K000665	TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER Tfx Medical, Inc.	FOZ
Apr 20, 2000	K992732	STERILE WATER & STERILE 0.9% SODIUM CHLORIDE Dumex Medical Surgical Products, Ltd., CA	FOZ
Apr 5, 2000	K000235	INSYTE CATHETER, INSYTE AUTOGUARD CATHETER Becton Dickinson Infusion Therapy Systems, Inc.	FOZ
Mar 17, 2000	K000087	MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR The Kendal Co.	FOZ
Mar 8, 2000	K993691	ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc.	FOZ
Mar 8, 2000	K982558	BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE Bd/Preefil	FOZ
Feb 25, 2000	K993515	MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L Medefil, Inc.	FOZ
Dec 10, 1999	K990390	HEPARIN IV FLUSH SYRINGE, 10 U/ML \ Rocap Div. of Sabratek Corp.	FOZ
Dec 10, 1999	K990308	ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML Rocap Div. of Sabratek Corp.	FOZ
Oct 7, 1999	K984590	0.9% SODIUM CHLORIDE FLUSH SYRINGE Baxter Healthcare Corp	FOZ
Aug 27, 1999	K992198	URETHANE PICC LINE MODEL UPICS- Cook, Inc.	FOZ
Aug 20, 1999	K990236	*MODIFICATION OF JELCO,JELCO-W AND JELCO PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT** Johnson & Johnson Medical, Div. of Ethicon, Inc.	FOZ
Jun 16, 1999	K991406	TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER Terumo Medical Corp.	FOZ
May 27, 1999	K984614	NORMAL SALINE FLUSH SYRINGE Rocap Div. of Sabratek Corp.	FOZ
May 5, 1999	K984189	ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER Maxxim Medical	FOZ
Apr 9, 1999	K984059	ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic	FOZ
Jan 29, 1999	K984055	CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS Sims Deltec, Inc.	FOZ
Jan 14, 1999	K982805	INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc.	FOZ
Dec 16, 1998	K970736	BRAUN PREFILLED SYRINGE B.Braun Medical, Inc.	FOZ
Nov 23, 1998	K983916	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) Hdc Corp.	FOZ
Oct 16, 1998	K983409	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 Hdc Corp.	FOZ
Sep 14, 1998	K980566	VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER Boston Scientific Corp	FOZ
Aug 18, 1998	K981905	STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 Acu-Pak	FOZ
May 18, 1998	K974015	ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL Davis & Geck, Inc.	FOZ
May 11, 1998	K973561	MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M Medical Components, Inc.	FOZ
May 1, 1998	K981382	PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS Catheter Innovations, Inc.	FOZ
May 1, 1998	K981368	PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS Catheter Innovations, Inc.	FOZ
Apr 28, 1998	K980493	I.V. CATHETER SYSTEM Johnson & Johnson Medical, Inc.	FOZ
Feb 26, 1998	K974764	INTROSYTE CATHETER Becton Dickinson Infusion Therapy Systems, Inc.	FOZ
Feb 10, 1998	K974543	L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER Luther Medical Products, Inc.	FOZ
Dec 24, 1997	K971339	INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS Becton Dickinson Vascular Access, Inc.	FOZ
Nov 7, 1997	K971991	GESCO PER-Q-CATH MIDLINE CATHETERS Bard Access Systems, Inc.	FOZ
Nov 7, 1997	K971990	GESCO PER-Q-CATH PICC CATHETERS Bard Access Systems, Inc.	FOZ
Oct 17, 1997	K970864	ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS Arrow Intl., Inc.	FOZ
Sep 15, 1997	K972264	FIRST MIDCATH CATHETER Becton Dickinson Infusion Therapy Systems, Inc.	FOZ
Sep 15, 1997	K972263	FIRST PICC CATHETER WITH DUAL LUMENS Becton Dickinson Infusion Therapy Systems, Inc.	FOZ

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