Atlas FDA

BARD-PARKER OCCLUSION BALLOON CATHETER

FDA 510(k) clearance K852294 · decided 1985-09-17

Clearance details

K-number
K852294
Device name
BARD-PARKER OCCLUSION BALLOON CATHETER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Decision
Substantially Equivalent
Date received
1985-05-29
Decision date
1985-09-17
Days to decision
111 days
Clearance type
Traditional
Product code
DYG
Device class
2
Regulation number
870.1240
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Washington, DC, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Bd Becton Dickinson Vacutainer Systems Preanalytic

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (K242451)Edwards Lifesciences2024-12-09
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) (K233983)Edwards Lifesciences2024-06-27
Swan-Ganz catheter (K233824)Edwards Lifesciences, LLC2024-06-06
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (K231248)Edwards Lifesciencess, LLC2023-09-21
Swang-Ganz IQ pulmonary artery catheter (K222117)Edwards Lifesiences, LLC2022-12-09
Swan-Ganz Catheters (K193466)Edwards Lifesciences, LLC2020-02-16
Swan Ganz Catheters (K160084)Edwards Lifesciences, LLC2016-05-03
PERCUPRO MESSENGER BALLOON CATHETER (K094048)Cardiosolutions, Inc.2011-07-14
OCCLUSION BALLOON CATHETER, MODEL VENOS (K081052)Oscor, Inc.2008-06-18
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 (K010253)Transonic Systems, Inc.2002-03-19
ATTAIN 6215 VENOGRAM BALLOON CATHETER (K012225)Medtronic Vascular2001-08-28
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 (K003118)Zcv ,Inc.2000-12-20

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
MINI BALLOON (P780011/S012)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-30
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MINI BALLOON (P780011/S010)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-29
MINI BALLOON (P780011/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-23
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05