Adult Vent Catheter
FDA 510(k) K834352 · Dlp, Inc.
510(k) numberK834352
Submission
- Device name
- Adult Vent Catheter
- Applicant
- Dlp, Inc.
Walker, MI, US - Received
- December 13, 1983
- Decision date
- January 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | 04/25/1995SE |
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| K914608 | Breast Les Local Wire St. 48219/49220/48119/48120GAA · Traditional | 01/09/1992SE |
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| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
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Questions and answers
When was Adult Vent Catheter cleared by the FDA?
Adult Vent Catheter (K834352) received a 510(k) decision of Substantially Equivalent on January 27, 1984, 45 days after the submission was received.
What is the product code of K834352?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.