Dravon T Clamp
FDA 510(k) K831842 · Dravon Medical, Inc.
510(k) numberK831842
Submission
- Device name
- Dravon T Clamp
- Applicant
- Dravon Medical, Inc.
Mchenry, IL, US - Received
- June 8, 1983
- Decision date
- September 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDC – Instrument, Surgical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K936226 | Surgimed Breast Localization Needle Wire SetKDC · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/07/1994SE |
| K920153 | Thermuff BagKDC · Traditional | Techstyles | 07/01/1992SE |
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| K914960 | Instrument OrganizerKDC · Traditional | O.R. Concepts, Inc. | 02/28/1992SE |
| K912834 | Shur-GripKDC · Traditional | Inman Medical Corp. | 07/26/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | Applied Vascular Devices, Inc. | 02/27/1991SE |
| K905240 | VesseloopsKDC · Traditional | Sparta Surgical Corp. | 02/06/1991SE |
| K903649 | Bradley Tenaculum HolderKDC · Traditional | Marlo Surgical Technology | 11/02/1990SE |
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| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | 03/12/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | 02/27/1979SE |
| K782057 | Catheter, Radiopaque TenckhoffFJS · Traditional | 02/27/1979SE |
| K781755 | Dap-PakKDJ · Traditional | 02/15/1979SE |
Questions and answers
When was Dravon T Clamp cleared by the FDA?
Dravon T Clamp (K831842) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 110 days after the submission was received.
What is the product code of K831842?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.