Atlas FDA

LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS

FDA 510(k) clearance K904440 · decided 1991-06-07

Clearance details

K-number
K904440
Device name
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
Applicant
Preferred Medical Products
Decision
Substantially Equivalent
Date received
1990-09-28
Decision date
1991-06-07
Days to decision
252 days
Clearance type
Traditional
Product code
CAZ
Device class
2
Regulation number
868.5140
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Gurnee, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intende recall (Z-1444-2013)I-Flow LLC2013-06-03
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended us recall (Z-1445-2013)I-Flow LLC2013-06-03
Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Balla recall (Z-0865-06)Kimberly-Clark Corporation2006-05-16
Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Manufactured by Balla recall (Z-0866-06)Kimberly-Clark Corporation2006-05-16
Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only * Manufactured by recall (Z-0867-06)Kimberly-Clark Corporation2006-05-16
Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only * Manufacture recall (Z-0868-06)Kimberly-Clark Corporation2006-05-16
Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only * Manufactured by B recall (Z-0869-06)Kimberly-Clark Corporation2006-05-16