Guide Wire
FDA 510(k) K870664 · Datascope Corp.
510(k) numberK870664
Submission
- Device name
- Guide Wire
- Applicant
- Datascope Corp.
Oakland, NJ, US - Received
- February 19, 1987
- Decision date
- March 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Guide Wire cleared by the FDA?
Guide Wire (K870664) received a 510(k) decision of Substantially Equivalent on March 25, 1987, 34 days after the submission was received.
What is the product code of K870664?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.