Disposable Angiography Needles
FDA 510(k) K890209 · E-Z-Em, Inc.
510(k) numberK890209
Submission
- Device name
- Disposable Angiography Needles
- Applicant
- E-Z-Em, Inc.
Marlboro, NJ, US - Received
- January 17, 1989
- Decision date
- May 19, 1989
- 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 Disposable Angiography Needles cleared by the FDA?
Disposable Angiography Needles (K890209) received a 510(k) decision of Substantially Equivalent on May 19, 1989, 122 days after the submission was received.
What is the product code of K890209?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.