Puncture Kit, Internal Jugular
FDA 510(k) K770462 · Arrow Intl., Inc.
510(k) numberK770462
Submission
- Device name
- Puncture Kit, Internal Jugular
- Applicant
- Arrow Intl., Inc.
Mchenry, IL, US - Received
- March 9, 1977
- Decision date
- March 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Puncture Kit, Internal Jugular cleared by the FDA?
Puncture Kit, Internal Jugular (K770462) received a 510(k) decision of Substantially Equivalent on March 14, 1977, 5 days after the submission was received.
What is the product code of K770462?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.