Micro-Stick Set
FDA 510(k) K091954 · Medcomp
510(k) numberK091954
Submission
- Device name
- Micro-Stick Set
- Applicant
- Medcomp
Harleysville, PA, US - Received
- July 1, 2009
- Decision date
- January 8, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K130889 | Split Cath RGMSD · Traditional | 04/28/2014SESK |
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| K102966 | 2.6F X 20CM Vascu-Picc, 2.6F X 50CM Vascu-PiccLJS · Traditional | 12/21/2010SE |
| K092347 | Pro-Picc CTLJS · Special | 09/16/2009SE |
| K091953 | Pro-PiccLJS · Traditional | 09/16/2009SE |
| K090394 | Valved Tearway IntroducerDYB · Traditional | 09/01/2009SE |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple LumenLJS · Traditional | 07/23/2009SE |
| K091466 | 1.9F X 20CM Vascu-Picc, 1.9F X 50CM Vascu-Picc, Model VPI.9S20, VPI.9S50LJS · Special | 06/17/2009SE |
| K081775 | The Medcomp .010 Vascular GuidewiresDQX · Traditional | 03/25/2009SE |
| K081904 | Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)LJS · Traditional | 09/23/2008SE |
Questions and answers
When was Micro-Stick Set cleared by the FDA?
Micro-Stick Set (K091954) received a 510(k) decision of Substantially Equivalent on January 8, 2010, 191 days after the submission was received.
What is the product code of K091954?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.