Atlas FDA

CORDIS GRAVITY COMPENSATING ACCESSORY

FDA 510(k) clearance K932429 · decided 1994-07-20

Clearance details

K-number
K932429
Device name
CORDIS GRAVITY COMPENSATING ACCESSORY
Applicant
Cordis Corp.
Decision
Substantially Equivalent
Date received
1993-05-20
Decision date
1994-07-20
Days to decision
426 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Miami Lakes, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Cordis Corp.

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
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) (K261004)Integra Lifesciences Production Corporation2026-06-23
Intellidrop (K251598)Brainspace, Inc.2025-12-10
Sophy Mini Monopressure Valve (SM1) (K250636)Sophysa2025-11-28
EVAC-MRI (K252514)Phasor Health, LLC2025-11-05
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (K243531)Integra Lifesciences Production Corporation2025-08-08
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (K243552)Integra Lifesciences Production Corporation2025-08-06
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters (K242974)Sophysa2025-06-20
EVAC (K243205)Phasor Health, LLC2025-06-03
Duet External Drainage and Monitoring System (EDMS) (K243676)Medtronic Neurosurgery2025-03-10
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (K242003)Aesculap, Inc.2024-12-16
Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (K241458)Borvo Medical, Inc.2024-08-20
Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (K233445)Integra Lifesciences Production Corporation2024-01-17

Recalls involving this device

RecordFirmDate
Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF shu recall (Z-0458-2009)Integra LifeSciences Corp.2008-12-12

PMA approvals by this applicant

RecordFirmDate
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086)Cordis Corp.2014-10-10
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082)Cordis Corp.2012-01-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085)Cordis Corp.2012-01-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059)Cordis Corp.2011-05-27
CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083)Cordis Corp.2011-05-27
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081)Cordis Corp.2011-03-03
CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026)Cordis Corp.2011-02-22
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078)Cordis Corp.2010-09-02