LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS— 510(k) K904440
Substantially EquivalentPreferred Medical Products
FDA 510(k) clearance K904440 for LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS, Substantially Equivalent on 1991-06-07. Applicant: Preferred Medical Products. Device class: 2.
Clearance details
- Applicant
- Preferred Medical Products
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gurnee, IL, US
Recent devices under product code CAZ
view allMore clearances from Preferred Medical Products
view allAdverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K904440
K-number listed on FDA's recall record- Z-1444-2013 — I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
- Z-1445-2013 — I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904440.
Data sourced from openFDA. This site is unofficial and independent of the FDA.