DeviceClearance

SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR— 510(k) K063240

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K063240 for SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR, Substantially Equivalent on 2006-11-21. Applicant: C.R. Bard, Inc.. Device class: 2.

Clearance details

Applicant
C.R. Bard, Inc.
Product code
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
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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More clearances from C.R. Bard, Inc.

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Adverse 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 →

Recalls naming K063240

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063240.

Data sourced from openFDA. This site is unofficial and independent of the FDA.