Deseret Angio-Guide Large Vein Cath.
FDA 510(k) K833092 · Warner-Lambert Co.
510(k) numberK833092
Submission
- Device name
- Deseret Angio-Guide Large Vein Cath.
- Applicant
- Warner-Lambert Co.
Mchenry, IL, US - Received
- September 12, 1983
- Decision date
- November 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
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| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
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| K861510 | Multilumen Viapic Central Line CatheterFOZ · Traditional | 06/09/1986SE |
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| K852689 | General Diagnostics Ceftazidime 30 MCG Susc DiskJTN · Traditional | 08/19/1985SE |
| K852843 | General Diagnostics Coag-A-Mate XCKQC · Traditional | 08/13/1985SE |
| K852889 | General Diagnostics Rapid E. Coli TestJTO · Traditional | 07/23/1985SE |
| K850486 | General Diag. Chromostrate Heparin AssayKFF · Traditional | 05/08/1985SE |
| K850412 | Gen. Diag. Chromostrate Antithrombin III AssayJBQ · Traditional | 05/08/1985SE |
Questions and answers
When was Deseret Angio-Guide Large Vein Cath. cleared by the FDA?
Deseret Angio-Guide Large Vein Cath. (K833092) received a 510(k) decision of Substantially Equivalent on November 21, 1983, 70 days after the submission was received.
What is the product code of K833092?
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.