Angiographic Soft Tip Catheter
FDA 510(k) K914199 · E-Z-Em, Inc.
510(k) numberK914199
Submission
- Device name
- Angiographic Soft Tip Catheter
- Applicant
- E-Z-Em, Inc.
Glens Falls, NY, US - Received
- September 19, 1991
- Decision date
- December 18, 1991
- 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 Soft Tip Catheter cleared by the FDA?
Angiographic Soft Tip Catheter (K914199) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 90 days after the submission was received.
What is the product code of K914199?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.