CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.— 510(k) K951949
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K951949 for CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA., Substantially Equivalent on 1995-08-11. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
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Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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.