Peripheral Vascular Sheath Tunneler Sterilization Cassette
FDA 510(k) K042062 · Bard Peripheral Vascular, Inc.
510(k) numberK042062
Submission
- Device name
- Peripheral Vascular Sheath Tunneler Sterilization Cassette
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- August 2, 2004
- Decision date
- September 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
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Questions and answers
When was Peripheral Vascular Sheath Tunneler Sterilization Cassette cleared by the FDA?
Peripheral Vascular Sheath Tunneler Sterilization Cassette (K042062) received a 510(k) decision of Substantially Equivalent on September 30, 2004, 59 days after the submission was received.
What is the product code of K042062?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.