Acuity Pro Lead Delivery System
FDA 510(k) K132914 · Boston Scientific
510(k) numberK132914
Submission
- Device name
- Acuity Pro Lead Delivery System
- Applicant
- Boston Scientific
Maple Grove, MN, US - Received
- September 17, 2013
- Decision date
- April 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Acuity Pro Lead Delivery System cleared by the FDA?
Acuity Pro Lead Delivery System (K132914) received a 510(k) decision of Substantially Equivalent on April 3, 2014, 198 days after the submission was received.
What is the product code of K132914?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.