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ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO

FDA 510(k) clearance K970857 · decided 1997-11-05

Clearance details

K-number
K970857
Device name
ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
Applicant
Davis & Geck, Inc.
Decision
Substantially Equivalent
Date received
1997-03-10
Decision date
1997-11-05
Days to decision
240 days
Clearance type
Traditional
Product code
CAC
Device class
2
Regulation number
868.5830
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
St. Louis, MO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S008)Davis & Geck, Inc.1996-11-15
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (P840051/S007)Davis & Geck, Inc.1996-01-11
NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE (P840041/S006)Davis & Geck, Inc.1996-01-11
NOVAFIL(TM) (P840041/S005)Davis & Geck, Inc.1994-04-20
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S006)Davis & Geck, Inc.1992-03-24
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005)Davis & Geck, Inc.1991-10-17
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004)Davis & Geck, Inc.1991-03-29
NOVAFIL(TM) (P840041/S003)Davis & Geck, Inc.1990-07-06