Edslab (R) Occlusion Balloon Catheter
FDA 510(k) K873485 · American Edwards Laboratories
510(k) numberK873485
Submission
- Device name
- Edslab (R) Occlusion Balloon Catheter
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- August 31, 1987
- Decision date
- December 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Edslab (R) Occlusion Balloon Catheter cleared by the FDA?
Edslab (R) Occlusion Balloon Catheter (K873485) received a 510(k) decision of Substantially Equivalent on December 3, 1987, 94 days after the submission was received.
What is the product code of K873485?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.