Angeion Endoscopic Valve Seal
FDA 510(k) K915719 · Angeion Corp.
510(k) numberK915719
Submission
- Device name
- Angeion Endoscopic Valve Seal
- Applicant
- Angeion Corp.
Plymouth, MN, US - Received
- December 20, 1991
- Decision date
- February 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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| K895580 | Y-Adapter W/Thouy BorstDYB · Traditional | 04/30/1990SE |
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Questions and answers
When was Angeion Endoscopic Valve Seal cleared by the FDA?
Angeion Endoscopic Valve Seal (K915719) received a 510(k) decision of Substantially Equivalent on February 18, 1992, 60 days after the submission was received.
What is the product code of K915719?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.