Clear or Braided Contrast Media Injection Line with or Without Rotator, Cath Lab Kit
FDA 510(k) K011217 · Abbott Laboratories
510(k) numberK011217
Submission
- Device name
- Clear or Braided Contrast Media Injection Line with or Without Rotator, Cath Lab Kit
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 20, 2001
- Decision date
- May 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Clear or Braided Contrast Media Injection Line with or Without Rotator, Cath Lab Kit cleared by the FDA?
Clear or Braided Contrast Media Injection Line with or Without Rotator, Cath Lab Kit (K011217) received a 510(k) decision of Substantially Equivalent on May 16, 2001, 26 days after the submission was received.
What is the product code of K011217?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.