Seal-Away Hemostasis Adapter, Model 406229
FDA 510(k) K984062 · Diag Corp.
510(k) numberK984062
Submission
- Device name
- Seal-Away Hemostasis Adapter, Model 406229
- Applicant
- Diag Corp.
Minnetonka, MN, US - Received
- November 16, 1998
- Decision date
- March 24, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Seal-Away Hemostasis Adapter, Model 406229 cleared by the FDA?
Seal-Away Hemostasis Adapter, Model 406229 (K984062) received a 510(k) decision of Substantially Equivalent on March 24, 1999, 128 days after the submission was received.
What is the product code of K984062?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.