FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇷 Costa Rica
PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
K Number: K926338
·
Decision Jul 26, 1994
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
37
Review Days
585
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Basic Information
- Device Name
- PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
- K Number
- K926338
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deknatel, Inc.
- Date Received
- December 18, 1992
- Decision Date
- July 26, 1994
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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Other Clearances by Deknatel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963850 | PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | Apr 22, 1997 | Substantially Equivalent |
| K962683 | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR | Jan 10, 1997 | Substantially Equivalent |
| K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | Dec 31, 1996 | Substantially Equivalent |
| K963098 | PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100) | Nov 8, 1996 | Substantially Equivalent |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | Aug 28, 1996 | Substantially Equivalent |
| K925243 | DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER | Jul 27, 1994 | Substantially Equivalent |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | Jul 26, 1994 | Substantially Equivalent |
| K930740 | SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL | Jul 26, 1994 | Substantially Equivalent |
| K930739 | SUTURES POLYPROP., POLYETHELINE, NYLON & SILK | Jul 26, 1994 | Substantially Equivalent |
| K931106 | BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT | Oct 6, 1993 | Substantially Equivalent |