Silicone Surgical Vessel Loops
FDA 510(k) K791370 · Conphar, Inc.
510(k) numberK791370
Submission
- Device name
- Silicone Surgical Vessel Loops
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- July 24, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
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| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
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Questions and answers
When was Silicone Surgical Vessel Loops cleared by the FDA?
Silicone Surgical Vessel Loops (K791370) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 10 days after the submission was received.
What is the product code of K791370?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.