FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAXTER APD 12' EXTENSION LINE
K Number: K925403
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
505
Review Days
487
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Basic Information
- Device Name
- BAXTER APD 12' EXTENSION LINE
- K Number
- K925403
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- October 23, 1992
- Decision Date
- February 22, 1994
- Product Code
- KDJ
- 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDJ), ordered by most recent decision date.
staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
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staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
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Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
FDA 510(k)
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Other Clearances by Baxter Healthcare Corp
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| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | Oct 8, 2013 | Substantially Equivalent |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO | Mar 1, 2013 | Substantially Equivalent |
| K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S | Jan 10, 2013 | Substantially Equivalent |
| K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET | Jan 8, 2013 | Substantially Equivalent |
| K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | Jun 29, 2012 | Substantially Equivalent |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Dec 8, 2011 | Substantially Equivalent |
| K111217 | ADDITIVE CAP | Jun 14, 2011 | Substantially Equivalent |