PER-Q-CATH MID-LINE— 510(k) K954422
Substantially EquivalentGesco Intl., Inc.
FDA 510(k) clearance K954422 for PER-Q-CATH MID-LINE, Substantially Equivalent on 1995-12-15. Applicant: Gesco Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Gesco Intl., 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
- Traditional
- Location
- Woburn, MA, US
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More clearances from Gesco Intl., Inc.
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.