Scoutpro CS Lead Introducer System
FDA 510(k) K080988 · Biotronik, Inc.
510(k) numberK080988
Submission
- Device name
- Scoutpro CS Lead Introducer System
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- April 7, 2008
- Decision date
- May 7, 2008
- Decision
- Substantially Equivalent (SESE)
- 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 Scoutpro CS Lead Introducer System cleared by the FDA?
Scoutpro CS Lead Introducer System (K080988) received a 510(k) decision of Substantially Equivalent on May 7, 2008, 30 days after the submission was received.
What is the product code of K080988?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.