CANALIZER HYDROPHILIC GUIDE WIRE— 510(k) K050873
Substantially EquivalentMedical Device Technologies, Inc.
FDA 510(k) clearance K050873 for CANALIZER HYDROPHILIC GUIDE WIRE, Substantially Equivalent on 2005-05-26. Applicant: Medical Device Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Device Technologies, Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Recent devices under product code DQX
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view all- K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
- K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
- K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.