510(k) K921091
- Device
- Cholangiolapcath(tm)
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K921091
- Product code
- GBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-06
- Date received
- 1992-03-06
- Regulation
- 878.4200
- Classification name
- Catheter, Cholangiography
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ARNSBERGER
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 1423537
- 9616567
- 3007695959
- 3003898360
- 1828132
- 3009888344
- 9680515
- 1836161
- 3021767551
- 1220477
- 1043214
- 1211566
- 1000151187
- 3011175548
- 9616683
- 3004638532
- 1062668
- 3043007473
- 3012104670
- 3005099803
- 3030446844
- 2431166
- 1223009
- 3004111573
- 8043548
- 9680794
- 1000121056
- 3009495876
- 1825146
- 3014579161
- 2424366
- 1055890
- 8010877
- 3009889060
- 3015997711
- 8030607
- 9680718
- 3013162291
- 1643817
- 2936485
- 9616088
- 3015895045
- 3010131137
- 3009513193
- 3012307300
- 1820334
- 8010298
- 3011137372
- 1319639
- 9681260
- 1061124
- 3005273623
- 3005012805
- 3010041511
- 3003915875
- 1828424
- 3004365956
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GBZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973621 | PRE-VIEW CHOLANGIOGRAPHY CLAMP | Nashville Surgical Instruments | 1997-12-17 |
| K944790 | FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Applied Medical Resources | 1994-11-29 |
| K942450 | ENDOPATH | Ethicon Endo-Surgery, Inc. | 1994-08-05 |
| K932228 | MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER | Boston Scientific Corp | 1993-08-10 |
| K926217 | TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE | Terumo Medical Corp. | 1993-07-13 |
| K926143 | ANGIOLAPCATH CHOLANGIOGRAPHY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-07-07 |
| K924212 | STRYKER ENDOSCOPY CHOLANGIOGRAM KIT | Stryker Corp. | 1993-07-07 |
| K925742 | CLARUS CHOLANGIOGRAM CATHETER KIT | Clarus Medical Systems, Inc. | 1993-06-01 |
| K924981 | OPERATIVE CHOLANGIOGRAM CATHETER | Taut, Inc. | 1993-04-06 |
| K924480 | CHOLANGIOGRAPHY CLAMP | Applied Medical Resources | 1993-03-03 |
| K924128 | CHOLANGIOGRAPHY CATHETER | Applied Medical Resources | 1993-02-10 |
| K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE | O.R. Concepts, Inc. | 1992-05-06 |
| K914015 | CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP | Pilling Co. | 1991-11-21 |
| K903709 | SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH | Lifestream Int'L, Inc. | 1990-10-26 |
| K901520 | WURTZ CHOLEY CLIP (TM) | Cd Medical, Inc. | 1990-06-26 |