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FDA 510(k)

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT

K-Number: K861677 · 1986-06-16

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1986-06-16
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K861677. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT?

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K861677.

When did PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT receive FDA 510(k) clearance?

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT received FDA 510(k) clearance on 1986-06-16, under 510(k) number K861677.

Who is the listed applicant for PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT?

The FDA product code for PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT is CAC.

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Other records listing American Pharmaseal Div. Ahsc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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Related Devices (Code: CAC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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