ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)— 510(k) K121501
Substantially EquivalentArrow International (Subsidiary of Teleflex Inc.)
FDA 510(k) clearance K121501 for ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC), Substantially Equivalent on 2012-11-29. Applicant: Arrow International (Subsidiary of Teleflex Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International (Subsidiary of Teleflex 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
- Reading, PA, US
Recent devices under product code LJS
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- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Arrow International (Subsidiary of Teleflex 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.