Olympus Angioscopy Irrigation Sheath
FDA 510(k) K910933 · Olympus Corp.
510(k) numberK910933
Submission
- Device name
- Olympus Angioscopy Irrigation Sheath
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- March 6, 1991
- Decision date
- June 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Olympus Angioscopy Irrigation Sheath cleared by the FDA?
Olympus Angioscopy Irrigation Sheath (K910933) received a 510(k) decision of Substantially Equivalent on June 3, 1991, 89 days after the submission was received.
What is the product code of K910933?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.