Siteseer Angiographic Catheter
FDA 510(k) K980575 · C.R. Bard, Inc.
510(k) numberK980575
Submission
- Device name
- Siteseer Angiographic Catheter
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- February 17, 1998
- Decision date
- May 15, 1998
- 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 Siteseer Angiographic Catheter cleared by the FDA?
Siteseer Angiographic Catheter (K980575) received a 510(k) decision of Substantially Equivalent on May 15, 1998, 87 days after the submission was received.
What is the product code of K980575?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.