Scanlan Heifetz Aneurysm Elgiloy Clip System
FDA 510(k) K960372 · Scanlan Intl., Inc.
510(k) numberK960372
Submission
- Device name
- Scanlan Heifetz Aneurysm Elgiloy Clip System
- Applicant
- Scanlan Intl., Inc.
Saint Paul, MN, US - Received
- January 26, 1996
- Decision date
- April 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K031468 | Temporary Titanium Aneurysm ClipHCH · Traditional | Cardinalhealth | 06/20/2003SE |
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Questions and answers
When was Scanlan Heifetz Aneurysm Elgiloy Clip System cleared by the FDA?
Scanlan Heifetz Aneurysm Elgiloy Clip System (K960372) received a 510(k) decision of Substantially Equivalent on April 26, 1996, 91 days after the submission was received.
What is the product code of K960372?
The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.