GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE— 510(k) K951448
Substantially EquivalentGlobal Medical Products, Ltd.
FDA 510(k) clearance K951448 for GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE, Substantially Equivalent on 1996-03-27. Applicant: Global Medical Products, Ltd.. Device class: 2.
Clearance details
- Applicant
- Global Medical Products, Ltd.
- Product code
- Code DRC
- Device class
- Class 2
- Regulation
- 21 CFR 870.1390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Road Town, Tortola, VG
Recent devices under product code DRC
view allMore clearances from Global Medical Products, Ltd.
view all- K962821 — EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
- K961444 — GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
- K951421 — GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREENE NEEDLES
- K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
Adverse events under product code DRC
product code DRC- Death
- 28
- Injury
- 412
- Total
- 440
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.