FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERITONEAL DIALYSIS COIL CATHETER
K Number: K850247
·
Decision Feb 14, 1985
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
29
Review Days
23
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Basic Information
- Device Name
- PERITONEAL DIALYSIS COIL CATHETER
- K Number
- K850247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sil-Med Corp.
- Date Received
- January 22, 1985
- Decision Date
- February 14, 1985
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
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Other Clearances by Sil-Med Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K972521 | NAVIGATOR (STYLET) 2006 | Oct 1, 1997 | Substantially Equivalent |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | Jul 18, 1997 | Substantially Equivalent |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | Aug 8, 1996 | Substantially Equivalent |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Jun 26, 1996 | Substantially Equivalent |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Mar 11, 1996 | Substantially Equivalent |
| K955463 | GRIP-A-BOOTS | Jan 23, 1996 | Substantially Equivalent |
| K942709 | MEDIASTINAL SILICONE DRAINS | Jan 4, 1996 | Substantially Equivalent for Some Indications |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | May 24, 1995 | Substantially Equivalent |
| K926408 | SIL-SLIP FLAT SUCTION DRAIN | Feb 2, 1994 | Substantially Equivalent |
| K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE | Feb 2, 1994 | Substantially Equivalent |