091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
FDA 510(k) K172468 · Inneuroco, Inc.
510(k) numberK172468
Submission
- Device name
- 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
- Applicant
- Inneuroco, Inc.
Sunrise, FL, US - Received
- August 15, 2017
- Decision date
- December 6, 2017
- 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 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm cleared by the FDA?
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (K172468) received a 510(k) decision of Substantially Equivalent on December 6, 2017, 113 days after the submission was received.
What is the product code of K172468?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.