Dillard Nasal Balloon Catheter
FDA 510(k) K181546 · Intuit Medical Products, LLC
510(k) numberK181546
Submission
- Device name
- Dillard Nasal Balloon Catheter
- Applicant
- Intuit Medical Products, LLC
Sugar Hill, GA, US - Received
- June 12, 2018
- Decision date
- January 3, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRC – Instrument, Ent Manual Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
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| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | Acclarent, Inc. | 08/27/2020SE |
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| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 05/03/2019SE |
| K181838 | Sinusway Dilation SystemLRC · Traditional | 3nt Medical , Ltd. | 12/20/2018SE |
| K172737 | MESIRE - Balloon Sinus Dilatation SystemLRC · Traditional | M/S. Meril Life Sciences Private Limited | 12/12/2017SE |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC · Traditional | Acclarent, Inc. | 09/05/2017SE |
| K161698 | Relieva UltirraNav Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 10/24/2016SE |
More from Acclarent, Inc.
Questions and answers
When was Dillard Nasal Balloon Catheter cleared by the FDA?
Dillard Nasal Balloon Catheter (K181546) received a 510(k) decision of Substantially Equivalent on January 3, 2020, 570 days after the submission was received.
What is the product code of K181546?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.