Selectra Catheters and Selectra Accessory Kit
FDA 510(k) K151409 · Biotronik, Inc.
510(k) numberK151409
Submission
- Device name
- Selectra Catheters and Selectra Accessory Kit
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- May 26, 2015
- Decision date
- August 7, 2015
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 Selectra Catheters and Selectra Accessory Kit cleared by the FDA?
Selectra Catheters and Selectra Accessory Kit (K151409) received a 510(k) decision of Unknown on August 7, 2015, 73 days after the submission was received.
What is the product code of K151409?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.