Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter
FDA 510(k) K001578 · AngioDynamics, Inc.
510(k) numberK001578
Submission
- Device name
- Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- May 22, 2000
- Decision date
- October 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter cleared by the FDA?
Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter (K001578) received a 510(k) decision of Substantially Equivalent on October 13, 2000, 144 days after the submission was received.
What is the product code of K001578?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.