Biosense Webster Patient Cable and Leadwires
FDA 510(k) K001390 · Biosense Webster, Inc.
510(k) numberK001390
Submission
- Device name
- Biosense Webster Patient Cable and Leadwires
- Applicant
- Biosense Webster, Inc.
Diamond Bar, CA, US - Received
- May 2, 2000
- Decision date
- July 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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Questions and answers
When was Biosense Webster Patient Cable and Leadwires cleared by the FDA?
Biosense Webster Patient Cable and Leadwires (K001390) received a 510(k) decision of Substantially Equivalent on July 21, 2000, 80 days after the submission was received.
What is the product code of K001390?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.