Coron Pres Monitor Kit Model 80 Left Kit Model 90
FDA 510(k) K853072 · Camino Laboratories, Inc.
510(k) numberK853072
Submission
- Device name
- Coron Pres Monitor Kit Model 80 Left Kit Model 90
- Applicant
- Camino Laboratories, Inc.
San Diego, CA, US - Received
- July 23, 1985
- Decision date
- December 9, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Coron Pres Monitor Kit Model 80 Left Kit Model 90 cleared by the FDA?
Coron Pres Monitor Kit Model 80 Left Kit Model 90 (K853072) received a 510(k) decision of Substantially Equivalent on December 9, 1985, 139 days after the submission was received.
What is the product code of K853072?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.