Introducer with Distal Radiopaque Marker Band, Model OR-4926XX
FDA 510(k) K002847 · Maxxim Medical
510(k) numberK002847
Submission
- Device name
- Introducer with Distal Radiopaque Marker Band, Model OR-4926XX
- Applicant
- Maxxim Medical
Athens, TX, US - Received
- September 13, 2000
- Decision date
- May 31, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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 Introducer with Distal Radiopaque Marker Band, Model OR-4926XX cleared by the FDA?
Introducer with Distal Radiopaque Marker Band, Model OR-4926XX (K002847) received a 510(k) decision of Substantially Equivalent on May 31, 2001, 260 days after the submission was received.
What is the product code of K002847?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.