PORTEX EPIDURAL CATHETER— 510(k) K062005
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K062005 for PORTEX EPIDURAL CATHETER, Substantially Equivalent on 2006-10-18. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code BSO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5120
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Keene, NH, US
Recent devices under product code BSO
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- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets
- K181699 — Level 1 Convective Warmer
Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.