Datascope Percor Percutaneous Introducer W/Peelabl
FDA 510(k) K902932 · Datascope Corp.
510(k) numberK902932
Submission
- Device name
- Datascope Percor Percutaneous Introducer W/Peelabl
- Applicant
- Datascope Corp.
Oakland, NJ, US - Received
- July 3, 1990
- Decision date
- October 16, 1990
- 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 Datascope Percor Percutaneous Introducer W/Peelabl cleared by the FDA?
Datascope Percor Percutaneous Introducer W/Peelabl (K902932) received a 510(k) decision of Substantially Equivalent on October 16, 1990, 105 days after the submission was received.
What is the product code of K902932?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.