Arrow-Fischell Extended Vascular Access Needle
FDA 510(k) K924338 · Arrow Intl., Inc.
510(k) numberK924338
Submission
- Device name
- Arrow-Fischell Extended Vascular Access Needle
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- August 27, 1992
- Decision date
- March 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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Questions and answers
When was Arrow-Fischell Extended Vascular Access Needle cleared by the FDA?
Arrow-Fischell Extended Vascular Access Needle (K924338) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 203 days after the submission was received.
What is the product code of K924338?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.