E-Z-Flow Angiography Catheters, Modification
FDA 510(k) K914984 · E-Z-Em, Inc.
510(k) numberK914984
Submission
- Device name
- E-Z-Flow Angiography Catheters, Modification
- Applicant
- E-Z-Em, Inc.
Glens Falls, NY, US - Received
- October 23, 1991
- Decision date
- May 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was E-Z-Flow Angiography Catheters, Modification cleared by the FDA?
E-Z-Flow Angiography Catheters, Modification (K914984) received a 510(k) decision of Substantially Equivalent on May 20, 1992, 210 days after the submission was received.
What is the product code of K914984?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.