Luminary Cannulator Bideflectable Catheter with Lumen
FDA 510(k) K052575 · St Jude Medical
510(k) numberK052575
Submission
- Device name
- Luminary Cannulator Bideflectable Catheter with Lumen
- Applicant
- St Jude Medical
Minnetonka, MN, US - Received
- September 19, 2005
- Decision date
- January 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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Questions and answers
When was Luminary Cannulator Bideflectable Catheter with Lumen cleared by the FDA?
Luminary Cannulator Bideflectable Catheter with Lumen (K052575) received a 510(k) decision of Substantially Equivalent on January 19, 2006, 122 days after the submission was received.
What is the product code of K052575?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.