Advanset
FDA 510(k) K771261 · C.R. Bard, Inc.
510(k) numberK771261
Submission
- Device name
- Advanset
- Applicant
- C.R. Bard, Inc.
Mchenry, IL, US - Received
- July 11, 1977
- Decision date
- August 16, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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Questions and answers
When was Advanset cleared by the FDA?
Advanset (K771261) received a 510(k) decision of Substantially Equivalent on August 16, 1977, 36 days after the submission was received.
What is the product code of K771261?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.