Polyethylene Catheter
FDA 510(k) K181722 · Cook Incorporated
510(k) numberK181722
Submission
- Device name
- Polyethylene Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- June 29, 2018
- Decision date
- March 22, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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Questions and answers
When was Polyethylene Catheter cleared by the FDA?
Polyethylene Catheter (K181722) received a 510(k) decision of Substantially Equivalent on March 22, 2019, 266 days after the submission was received.
What is the product code of K181722?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.