Angiography Needle W/Wo Connection
FDA 510(k) K840923 · Dlp, Inc.
510(k) numberK840923
Submission
- Device name
- Angiography Needle W/Wo Connection
- Applicant
- Dlp, Inc.
Mchenry, IL, US - Received
- March 2, 1984
- Decision date
- April 17, 1984
- 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 Angiography Needle W/Wo Connection cleared by the FDA?
Angiography Needle W/Wo Connection (K840923) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 46 days after the submission was received.
What is the product code of K840923?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.