Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle
FDA 510(k) K951448 · Global Medical Products, Ltd.
510(k) numberK951448
Submission
- Device name
- Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle
- Applicant
- Global Medical Products, Ltd.
Road Town, Tortola, VG - Received
- March 29, 1995
- Decision date
- March 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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More from Synaptic Medical Limited
| 510(k) | Device | Decision |
|---|---|---|
| K970916 | H.V. Pulse Lavage (L31 Series)FQH · Traditional | 06/20/1997SE |
| K962821 | Epidural Anesthesia Kit and Combined Spinal Epidural Anesthesia KitCAZ · Traditional | 11/13/1996SESK |
| K961444 | Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)BSP · Traditional | 08/01/1996SE |
| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene NeedlesFCG · Traditional | 11/16/1995SE |
| K950311 | Global Medical Products Brest Lesion Localization Needle with Stiffened WireGDF · Traditional | 05/26/1995SE |
Questions and answers
When was Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle cleared by the FDA?
Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle (K951448) received a 510(k) decision of Substantially Equivalent on March 27, 1996, 364 days after the submission was received.
What is the product code of K951448?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.