Medline High Pressure Injection Tubing
FDA 510(k) K120008 · Medline Industries, Inc.
510(k) numberK120008
Submission
- Device name
- Medline High Pressure Injection Tubing
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- January 3, 2012
- Decision date
- August 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Medline High Pressure Injection Tubing cleared by the FDA?
Medline High Pressure Injection Tubing (K120008) received a 510(k) decision of Substantially Equivalent on August 17, 2012, 227 days after the submission was received.
What is the product code of K120008?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.