Angiographic Catheter, Model Angios
FDA 510(k) K092118 · Oscor, Inc.
510(k) numberK092118
Submission
- Device name
- Angiographic Catheter, Model Angios
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- July 14, 2009
- Decision date
- January 13, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Angiographic Catheter, Model Angios cleared by the FDA?
Angiographic Catheter, Model Angios (K092118) received a 510(k) decision of Substantially Equivalent on January 13, 2010, 183 days after the submission was received.
What is the product code of K092118?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.