FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
K Number: K881825
·
Decision Sep 28, 1988
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
13
Review Days
152
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH
- K Number
- K881825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Spectramed, Inc.
- Date Received
- April 29, 1988
- Decision Date
- September 28, 1988
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.
FieldFlex Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Echo Large Bore Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Introducer Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath+ introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Protaryx Transseptal Puncture Device (PTX2-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Spectramed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Jan 19, 1990 | Substantially Equivalent |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Nov 6, 1989 | Substantially Equivalent |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Oct 24, 1989 | Substantially Equivalent |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Aug 15, 1989 | Substantially Equivalent |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Feb 1, 1989 | Substantially Equivalent |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | Jan 25, 1989 | Substantially Equivalent |
| K875337 | HEPARIN COATED LUMINAL PACING CATHETER | May 25, 1988 | Substantially Equivalent |
| K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | Mar 22, 1988 | Substantially Equivalent |
| K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS | Jan 12, 1988 | Substantially Equivalent |
| K871573 | CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS | Sep 16, 1987 | Substantially Equivalent |