SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES— 510(k) K061240
Substantially EquivalentLucent Medical Systems
FDA 510(k) clearance K061240 for SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES, Substantially Equivalent on 2006-06-02. Applicant: Lucent Medical Systems. Device class: 2.
Clearance details
- Applicant
- Lucent Medical Systems
- Product code
- Product code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kirkland, WA, US
Recent devices under product code LJS
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- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
More clearances from Lucent Medical Systems
view allAdverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.