CVP Polyurethane Catheter
FDA 510(k) K961552 · Abbott Laboratories
510(k) numberK961552
Submission
- Device name
- CVP Polyurethane Catheter
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- April 22, 1996
- Decision date
- February 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
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| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
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| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
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Questions and answers
When was CVP Polyurethane Catheter cleared by the FDA?
CVP Polyurethane Catheter (K961552) received a 510(k) decision of Substantially Equivalent on February 10, 1997, 294 days after the submission was received.
What is the product code of K961552?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.