ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER— 510(k) K122854
Substantially EquivalentArrow International (Subsidiary of Teleflex Inc.)
FDA 510(k) clearance K122854 for ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER, Substantially Equivalent on 2013-01-04. Applicant: Arrow International (Subsidiary of Teleflex Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International (Subsidiary of Teleflex Inc.)
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code DYB
view allMore clearances from Arrow International (Subsidiary of Teleflex Inc.)
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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 K122854
K-number listed on FDA's recall record- Z-2699-2017 — Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
- Z-0207-2016 — ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122854.
Data sourced from openFDA. This site is unofficial and independent of the FDA.