FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
J-CATH(TM)
K Number: K875171
·
Decision Apr 6, 1988
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
30
Review Days
111
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Basic Information
- Device Name
- J-CATH(TM)
- K Number
- K875171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hdc Corp.
- Date Received
- December 17, 1987
- Decision Date
- April 6, 1988
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
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Other Clearances by Hdc Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K071875 | V-CATH POLY PICC | Nov 5, 2007 | Substantially Equivalent |
| K023342 | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | Mar 2, 2004 | Substantially Equivalent |
| K033853 | MODIFICATION TO V-CATH POLY PICC | Jan 14, 2004 | Substantially Equivalent |
| K032404 | SELDINGER SAFETY NEEDLE INTRODUCER | Sep 10, 2003 | Substantially Equivalent |
| K022752 | PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 | Sep 9, 2003 | Substantially Equivalent |
| K022099 | SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S | Sep 20, 2002 | Substantially Equivalent |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Mar 15, 2001 | Substantially Equivalent |
| K994059 | CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 | Oct 13, 2000 | Substantially Equivalent |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Sep 26, 2000 | Substantially Equivalent |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Mar 15, 1999 | Substantially Equivalent |