REGIONAL ANESTHESIA TRAYS— 510(k) K965017
UnknownSmiths Industries Medical Systems, Inc.
FDA 510(k) clearance K965017 for REGIONAL ANESTHESIA TRAYS, Unknown on 1997-03-14. Applicant: Smiths Industries Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Industries Medical Systems, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Keene, NH, US
Recent devices under product code CAZ
view allMore clearances from Smiths Industries Medical Systems, Inc.
view all- K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
- K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
- K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
- K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
- K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
Adverse 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 K965017
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K965017.
Data sourced from openFDA. This site is unofficial and independent of the FDA.