Atlas FDA

PIDURAL STEROID SYSTEM

FDA 510(k) clearance K945484 · decided 1995-06-02

Clearance details

K-number
K945484
Device name
PIDURAL STEROID SYSTEM
Applicant
Professional Medical Device Consultants
Decision
Unknown
Date received
1994-11-08
Decision date
1995-06-02
Days to decision
206 days
Clearance type
Traditional
Product code
CAZ
Device class
2
Regulation number
868.5140
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Sandy, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Onl recall (Z-0533-2014)Integra LifeSciences Corp. d.b.a. Integra Pain Management2013-12-17
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119 recall (Z-1943-2012)Integra LifeSciences Corp. d.b.a. Integra Pain Management2012-07-05
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B, Integra LifeSci recall (Z-2079-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06, Integra Lif recall (Z-2080-2009)Integra Life Sciences Corporation2009-09-21
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234, Integra LifeScience recall (Z-2081-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01, Integra recall (Z-2082-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378, Integra Li recall (Z-2083-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08, Integra recall (Z-2085-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02, Integra Life recall (Z-2086-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01, Integra recall (Z-2087-2009)Integra Life Sciences Corporation2009-09-21
Block Tray, Disposable, Convenience Kit, Reorder Number CUS835, Integra LifeSciences Corpo recall (Z-2088-2009)Integra Life Sciences Corporation2009-09-21
Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189, Integra Life recall (Z-2089-2009)Integra Life Sciences Corporation2009-09-21
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02, Integra LifeScie recall (Z-2090-2009)Integra Life Sciences Corporation2009-09-21
Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), recall (Z-2091-2009)Integra Life Sciences Corporation2009-09-21
Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01, Integra Life recall (Z-2092-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453, Integra Lif recall (Z-2093-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra Li recall (Z-2094-2009)Integra Life Sciences Corporation2009-09-21
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527, Integra LifeScience recall (Z-2095-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651, Integra LifeScie recall (Z-2096-2009)Integra Life Sciences Corporation2009-09-21
Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994, Integra LifeScienc recall (Z-2097-2009)Integra Life Sciences Corporation2009-09-21
CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder N recall (Z-2098-2009)Integra Life Sciences Corporation2009-09-21
Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES, I recall (Z-2099-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01, Integra recall (Z-2100-2009)Integra Life Sciences Corporation2009-09-21
Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278, Integra LifeScience recall (Z-2101-2009)Integra Life Sciences Corporation2009-09-21
South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01, Integra Lif recall (Z-2102-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619, Integra LifeSci recall (Z-2103-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756, Integra LifeSci recall (Z-2104-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01, Integra recall (Z-2105-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra Lif recall (Z-2106-2009)Integra Life Sciences Corporation2009-09-21
Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042, Integra Lif recall (Z-2107-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra recall (Z-2108-2009)Integra Life Sciences Corporation2009-09-21