Insitucat Valve Stripper
FDA 510(k) K885046 · Aesculap Instruments Corp.
510(k) numberK885046
Submission
- Device name
- Insitucat Valve Stripper
- Applicant
- Aesculap Instruments Corp.
Burlingame, CA, US - Received
- December 5, 1988
- Decision date
- February 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWQ – Stripper, Vein, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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| K872157 | Hall Vein StripperDWQ · Traditional | Solco Basle, Inc. | 07/07/1987SE |
| K811910 | Vein-Trap TMDWQ · Traditional | Atrium Medical Corp. | 07/20/1981SE |
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Questions and answers
When was Insitucat Valve Stripper cleared by the FDA?
Insitucat Valve Stripper (K885046) received a 510(k) decision of Substantially Equivalent on February 28, 1990, 450 days after the submission was received.
What is the product code of K885046?
The FDA product code is DWQ – Stripper, Vein, External, a Class II (moderate risk) device regulated under 21 CFR 870.4885.