Pathfinder II Angiographic Catheter
FDA 510(k) K990173 · Maxxim Medical
510(k) numberK990173
Submission
- Device name
- Pathfinder II Angiographic Catheter
- Applicant
- Maxxim Medical
Athens, TX, US - Received
- January 19, 1999
- Decision date
- December 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Pathfinder II Angiographic Catheter cleared by the FDA?
Pathfinder II Angiographic Catheter (K990173) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 336 days after the submission was received.
What is the product code of K990173?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.